## Protocol Section
### Identification Module
**NCT ID:** NCT00097279

**Acronym:** ACTION

**Brief Title:** Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

**Official Title:** A Multicenter, Open-Label, Randomised Trial to Compare the Efficacy and Safety of NovoLog Mix 70/30 BID in Combination With Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naïve Subjects With Type 2 Diabetes

#### Organization Study ID Info
**ID:** BIASP-2186
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
### Status Module
#### Completion Date
**Date:** 2005-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-08

**Type:** ACTUAL

#### Start Date
**Date:** 2004-08

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2004-11-22
**Type:** ESTIMATED
**Study First Submit Date:** 2004-11-19
**Study First Submit QC Date:** 2004-11-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.

### Conditions Module

**Conditions:**

- Diabetes

- Diabetes Mellitus, Type 2

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 230

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** biphasic insulin aspart

**Type:** DRUG

#### Intervention 2

**Name:** pioglitazone

**Type:** DRUG

#### Intervention 3

**Name:** metformin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** HbA1c

**Time Frame:** After 24 weeks

#### Secondary Outcomes

**Measure:** Safety variables

**Measure:** Other glycemic variables

**Measure:** 8-point plasma glucose profiles

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects with type 2 diabetes mellitus

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Alabama

**Zip:** 35235

**Location 2:**

**City:** Glendale

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Arizona

**Zip:** 85306

**Location 3:**

**City:** Phoenix

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Arizona

**Zip:** 85006

**Location 4:**

**City:** Searcy

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Arkansas

**Zip:** 72143

**Location 5:**

**City:** Burlingame

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 94010

**Location 6:**

**City:** Chula Vista

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 91911

**Location 7:**

**City:** Fullerton

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 92835

**Location 8:**

**City:** Los Angeles

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 90057

**Location 9:**

**City:** Redwood City

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 94062

**Location 10:**

**City:** Denver

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Colorado

**Zip:** 80262

**Location 11:**

**City:** New Britain

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Connecticut

**Zip:** 06050

**Location 12:**

**City:** Newark

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Delaware

**Zip:** 19713

**Location 13:**

**City:** Aventura

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 33180

**Location 14:**

**City:** Fort Myers

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 33907

**Location 15:**

**City:** Hollywood

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 33021

**Location 16:**

**City:** Lake Mary

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 32746

**Location 17:**

**City:** Melbourne

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 32901

**Location 18:**

**City:** Ocala

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 34471

**Location 19:**

**City:** Pembroke Pines

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 33024

**Location 20:**

**City:** Tallahassee

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 32308

**Location 21:**

**City:** West Palm Beach

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Florida

**Zip:** 33401

**Location 22:**

**City:** Atlanta

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Georgia

**Zip:** 30339

**Location 23:**

**City:** Columbus

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Georgia

**Zip:** 31904

**Location 24:**

**City:** Savannah

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Georgia

**Zip:** 31406

**Location 25:**

**City:** Boise

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Idaho

**Zip:** 83702

**Location 26:**

**City:** Chicago

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Illinois

**Zip:** 60607

**Location 27:**

**City:** Topeka

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Kansas

**Zip:** 66606

**Location 28:**

**City:** Wichita

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Kansas

**Zip:** 67205

**Location 29:**

**City:** Baton Rouge

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Louisiana

**Zip:** 70808

**Location 30:**

**City:** Easton

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Maryland

**Zip:** 21601

**Location 31:**

**City:** Danvers

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Massachusetts

**Zip:** 01923

**Location 32:**

**City:** Salisbury

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Massachusetts

**Zip:** 01952

**Location 33:**

**City:** Waltham

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Massachusetts

**Zip:** 02453

**Location 34:**

**City:** Detroit

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Michigan

**Zip:** 48235

**Location 35:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Michigan

**Zip:** 49506

**Location 36:**

**City:** Livonia

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Michigan

**Zip:** 48152

**Location 37:**

**City:** St. Cloud

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Minnesota

**Zip:** 56303

**Location 38:**

**City:** Columbia

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Missouri

**Zip:** 65212

**Location 39:**

**City:** Las Vegas

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Nevada

**Zip:** 89030

**Location 40:**

**City:** Reno

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Nevada

**Zip:** 89502-0111

**Location 41:**

**City:** Hampton

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New Hampshire

**Zip:** 03842

**Location 42:**

**City:** Berlin

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New Jersey

**Zip:** 08009

**Location 43:**

**City:** Turnersville

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New Jersey

**Zip:** 08012

**Location 44:**

**City:** East Syracuse

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New York

**Zip:** 13057

**Location 45:**

**City:** New York

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New York

**Zip:** 10003

**Location 46:**

**City:** New York

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New York

**Zip:** 10023

**Location 47:**

**City:** Greenville

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** North Carolina

**Zip:** 27834

**Location 48:**

**City:** Columbus

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Ohio

**Zip:** 43203

**Location 49:**

**City:** Dayton

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Ohio

**Zip:** 45406

**Location 50:**

**City:** Kettering

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Ohio

**Zip:** 45429

**Location 51:**

**City:** Medford

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Oregon

**Zip:** 97501

**Location 52:**

**City:** Melrose Park

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Pennsylvania

**Zip:** 19027

**Location 53:**

**City:** Philadelphia

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Pennsylvania

**Zip:** 19107

**Location 54:**

**City:** Greer

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** South Carolina

**Zip:** 29651

**Location 55:**

**City:** Chattanooga

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Tennessee

**Zip:** 37404

**Location 56:**

**City:** Arlington

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 76014

**Location 57:**

**City:** Dallas

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 75231

**Location 58:**

**City:** Dallas

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 75235

**Location 59:**

**City:** Dallas

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 75390-8858

**Location 60:**

**City:** Irving

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 75061

**Location 61:**

**City:** Midland

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 79707

**Location 62:**

**City:** San Antonio

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 78229

**Location 63:**

**City:** Ogden

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Utah

**Zip:** 84403

**Location 64:**

**City:** Newport News

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Virginia

**Zip:** 23606

**Location 65:**

**City:** Norfolk

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Virginia

**Zip:** 23507

**Location 66:**

**City:** Richmond

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Virginia

**Zip:** 23249

**Location 67:**

**City:** Suffolk

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Virginia

**Zip:** 23434

**Location 68:**

**City:** Warrenton

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Virginia

**Zip:** 20186

**Location 69:**

**City:** Kirkland

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Washington

**Zip:** 98034

**Location 70:**

**City:** Olympia

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Washington

**Zip:** 98502

**Location 71:**

**City:** Renton

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Washington

**Zip:** 98057

**Location 72:**

**City:** Tacoma

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Washington

**Zip:** 98405

**Location 73:**

**City:** Milwaukee

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Wisconsin

**Zip:** 53209

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

**Name:** Global Clinical Registry (GCR, 1452)

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A. Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab. 2009 Jan;11(1):27-32. doi: 10.1111/j.1463-1326.2007.00796.x. Epub 2007 Oct 17.

**PMID:** 17941873

#### See Also Links

**Label:** Clinical Trials at Novo Nordisk

**URL:** http://novonordisk-trials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11667

- Name: Metformin

- Relevance: HIGH

- As Found: Assessment

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M1693

- Name: Pioglitazone

- Relevance: HIGH

- As Found: Non-invasive

- ID: M29801

- Name: Insulin Aspart

- Relevance: HIGH

- As Found: Childhood

- ID: M29799

- Name: Biphasic Insulins

- Relevance: HIGH

- As Found: Importance

### Intervention Browse Module - Meshes

- ID: D000008687

- Term: Metformin

- ID: D000077205

- Term: Pioglitazone

- ID: D000061267

- Term: Insulin Aspart

- ID: D000061265

- Term: Biphasic Insulins

### Misc Info Module

- Version Holder: 2024-05-24
