Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2
Diabetes

Interventions: Drug: insulin glargine
Drug: insulin detemir

Registration Number: NCT00909480

Lead Sponsor: Novo Nordisk A/S

Brief Summary: This trial is conducted in Asia, South America and the United States of America (USA).

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 subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 457

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 dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 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/m^2

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
IGlar	insulin glargine	Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
IDet	insulin detemir	Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline	Week 0, Week 26

Secondary Outcome Measures

Name	Time	Method
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)	Week 26	Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%	Week 26	The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less
Hypoglycaemic Episodes, Diurnal	Weeks 0-26	Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Hypoglycaemic Episodes, Nocturnal	Weeks 0-26	Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Change in Body Weight From Baseline	Week 0, Week 26
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia	Week 26	The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%	Week 26	The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%
Incidence of Hypoglycaemic Episodes During the Trial	Weeks 0-26	Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia	Week 26	The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Fasting Plasma Glucose (FPG)	Week 26
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast	Week 26	The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.
Number of Subjects Having the Adverse Event "Incorrect Dose Administered"	Weeks 0-26	Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications"
Hypoglycemic Episodes, Unclassifiable	Weeks 0-26	Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.