Comparison of two NN1250 formulations versus insulin glargine, all in combination with metformin in subjects with type 2 diabetes

Phase 2

Completed

• Conditions: Diabetes mellitus, Diabetes Mellitus, Type 2,

• Registration Number: CTRI/2007/091/000042
• Lead Sponsor: Novo Nordisk AS

Brief Summary

The aim of the trial is to compare two NN1250 formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-01
• Study Completion: 2008-08-20
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Insulin naive type 2 subjects for at least 3 months 2.
• Treatment with a stable dosing of maximally tolerated dose or at least half maximally allowed dose of one or two OADs for at least 2 months 3.
• HbA1c 7.0-11.0% (both inclusive) 4.
• Body mass index (BMI) 25-42 kg/m2 (both inclusive).

Exclusion Criteria

• Metformin contraindication according to local practice 2.
• Treatment with thiazolidinedione (TZD) within the last 3 months prior to screening 3.
• Any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) 3 months prior to randomisation 4.
• Any disease or condition which according to the investigator would interfere with the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c	After 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
1. Plasma glucose profiles For the duration of the trial2. Incidence of hypoglycaemic episodes For the duration of the trial3. Frequency and severity of adverse events For the duration of the trial4. Laboratory safety parameters For the duration of the trial5. Physical examination and vital signs For the duration of the trial	After 16 weeks of treatment

Trial Locations

Locations (3)

Department of Endocrinology and Diabetes; 🇮🇳 Ernakulam, KERALA, India

Department of Endocrinology; 🇮🇳 Vellore, TAMIL NADU, India

Department of Endocrinologyand metabloism; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Department of Endocrinology and Diabetes

🇮🇳Ernakulam, KERALA, India

Dr Harish Kumar

Principal investigator

048428011234

diabetesresearch@aims.amrita.edu