Effect of insulin detemir and insulin glargine on blood glucose control in subjects with type 2 diabetes

Phase 4

Completed

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

• Registration Number: CTRI/2009/091/000161
• Lead Sponsor: Novo Nordisk AS

Brief Summary

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in type 2 diabetics inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD). 30 patients are proposed to be enrolled from India Total No of Subjects Enrolled In India:52 Trial ID:NN304-1768 Date of First Enrolment in India:13 Jul 2009

The study is completed globally

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-13
• Study Completion: 2010-07-06
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

Diagnosed with type 2 diabetes for at least 6 months Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or DPP-4 inhibitors) for at least 3 months Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed) HbA1c 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed) Body Mass Index (BMI) less than or equal to 35.0 kg/m2 Age 18 years and above.

Exclusion Criteria

Any contraindication to insulin detemir or insulin glargine according to the local labelling Receipt of any investigational product within 4 weeks Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids) Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product Any other condition that the Investigator feels would interfere with trial participation or evaluation of results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1C from baseline after 26 weeks of treatment	26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Glycaemic control as measured by fasting plasma glucose (FPG) (central laboratory values)	after 26 weeks of treatment
Change in body weight	26 weeks of treatment
Glycaemic control as measured by 9-point plasma glucose profile (self-measured)	after 26 weeks of treatment
Incidence of hypoglycaemic episodes during the trial: nocturnal and over 24 hours	after 26 weeks of treatment
Proportion of subjects achieving HbA1c of 6.5% or less	after 26 weeks of treatment
Proportion of subjects achieving HbA1c of 7.0% or less	after 26 weeks of treatment
Within-subject variation of self measured plasma glucose (SMPG) before breakfast during the trial	after 26 weeks of treatment

Trial Locations

Locations (2)

Jothydev Diabetes and Research Centre; 🇮🇳 Thiruvananthapuram, KERALA, India

Swamy Diabetes Centre; 🇮🇳 Chennai, TAMIL NADU, India

Jothydev Diabetes and Research Centre

🇮🇳Thiruvananthapuram, KERALA, India

Dr Jothydev

Principal investigator

Jothydev@asianet.com