## Protocol Section
### Identification Module
**NCT ID:** NCT00859079

**Brief Title:** Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients

**Official Title:** Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients

#### Organization Study ID Info
**ID:** TCW-GLP1-1
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Graz
### Status Module
#### Completion Date
**Date:** 2007-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-03-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-03-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-12

**Type:** ACTUAL

#### Start Date
**Date:** 2006-06

**Status Verified Date:** 2009-03

#### Study First Post Date
**Date:** 2009-03-10
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-07
**Study First Submit QC Date:** 2009-03-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of Graz

#### Responsible Party

**Old Name Title:** Dr. Thomas Wascher

**Old Organization:** Medical University of Graz

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

**Detailed Description:** Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.

In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.

The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

### Conditions Module

**Conditions:**

- Diabetes Mellitus Type 2

- Hyperglycemia

**Keywords:**

- diabetes mellitus type 2, GLP-1, insulin infusion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenously administered GLP-1

**Intervention Names:**

- Drug: GLP-1

**Label:** GLP-1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Insulin intravenously according to the Munich registry

**Intervention Names:**

- Drug: Human regular insulin intravenously

**Label:** Insulin intravenously

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GLP-1

**Description:** Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.

**Name:** GLP-1

**Other Names:**

- GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Insulin intravenously

**Description:** Human regular insulin intravenously according to the Munich-registry.

**Name:** Human regular insulin intravenously

**Other Names:**

- Insulin Actrapid, NovoNordisk, Denmark

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** time to reach a plasma glucose below 115 mg/dl

**Time Frame:** 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min

#### Secondary Outcomes

**Measure:** plasma glucose after 2 and 4 hours as well as maximum glycemia

**Time Frame:** 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min

**Measure:** number of hypoglycaemic episodes

**Time Frame:** 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Type 2 diabetes mellitus
* Fasting glycemia above 150 mg/dl
* Signed informed consent

Exclusion Criteria:

* Patients with heart failure \> NYHA II
* Uncontrolled hypertension
* Impaired kidney function (creatinine \> 3 mg/dl)
* Acute infection

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Graz

**Country:** Austria

**Facility:** Medical University of Graz, Department for Internal Medicine

**Zip:** 8036

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria

**Name:** Thomas C Wascher, MD

**Role:** PRINCIPAL_INVESTIGATOR

## 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 Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus Type 2

- ID: M9994

- Name: Hyperglycemia

- Relevance: HIGH

- As Found: Hyperglycemia

- 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: D000006943

- Term: Hyperglycemia

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000054795

- Term: Incretins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: HIGH

- As Found: Day 1

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: HIGH

- As Found: Day 1

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: HIGH

- As Found: Expected

- ID: M17768

- Name: Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007328

- Term: Insulin

- ID: C000557859

- Term: Insulin, Globin Zinc

- ID: D000052216

- Term: Glucagon-Like Peptide 1

### Misc Info Module

- Version Holder: 2024-05-24
