## Protocol Section
### Identification Module
**NCT ID:** NCT00699179

**Acronym:** EFFECTIVE

**Brief Title:** Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

**Official Title:** EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice

#### Organization Study ID Info
**ID:** BIASP-3557
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
### Status Module
#### Completion Date
**Date:** 2009-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-10-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-09

**Type:** ACTUAL

#### Start Date
**Date:** 2008-06

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2008-06-17
**Type:** ESTIMATED
**Study First Submit Date:** 2008-06-13
**Study First Submit QC Date:** 2008-06-16
### 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 study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

### Conditions Module

**Conditions:**

- Diabetes

- Diabetes Mellitus, Type 1

- Diabetes Mellitus, Type 2

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2308

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: biphasic insulin aspart 30

**Label:** A

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.

**Name:** biphasic insulin aspart 30

**Other Names:**

- NovoMix® 30

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in HbA1c from baseline

**Time Frame:** After 6 months

#### Secondary Outcomes

**Measure:** Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus

**Time Frame:** after 12 weeks and 26 weeks compared to baseline

**Measure:** Change in FPG (glucose variability)

**Time Frame:** after 12 weeks and 26 weeks compared to baseline

**Measure:** Change in PPG (postprandial control)

**Time Frame:** after 12 weeks and 26 weeks compared to baseline

**Measure:** Change in insulin dose and number of injections

**Time Frame:** at 12 weeks and 26 weeks of treatment

**Measure:** Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study

**Time Frame:** after 12 weeks and 26 weeks of treatment compared to baseline

**Measure:** Change in body weight and waist circumference

**Time Frame:** at 12 weeks and 26 weeks of treatment compared to baseline

**Measure:** Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits

**Time Frame:** at 12 weeks and 26 weeks of treatment compared to baseline

**Measure:** Number of adverse drug reactions (ADR)

**Time Frame:** after 12 weeks and 26 weeks of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
* HbA1c greater than 7%
* Informed Consent

Exclusion Criteria:

* Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
* Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Type 1 and 2 diabetes

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Belgrade

**Country:** Former Serbia and Montenegro

**Facility:** Novo Nordisk Investigational Site

**Zip:** 11 070

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

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

**Role:** STUDY_DIRECTOR

### References Module

#### 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

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune 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

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 1

- 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

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### 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

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M29801

- Name: Insulin Aspart

- Relevance: HIGH

- As Found: Childhood

- ID: M29799

- Name: Biphasic Insulins

- Relevance: HIGH

- As Found: Importance

- ID: M14342

- Name: Protamines

- Relevance: LOW

- As Found: Unknown

- ID: M350709

- Name: Insulin aspart, insulin aspart protamine drug combination 30:70

- Relevance: HIGH

- As Found: Differential

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000061267

- Term: Insulin Aspart

- ID: D000061265

- Term: Biphasic Insulins

- ID: C000557564

- Term: Insulin aspart, insulin aspart protamine drug combination 30:70

### Misc Info Module

#### Removed Countries

- Country: Serbia

- Version Holder: 2024-05-24
