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

Study Overview
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Brief Summary
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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).

Official Title
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A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDet<br>Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day | Drug: insulin detemir<br>* Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued<br>|
| Active Comparator: IGlar<br>Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day | Drug: insulin glargine<br>* Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline |  | Week 0, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% | Week 26 | 
| Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | 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. | Week 26 | 
| Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less | Week 26 | 
| Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | 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. | Week 26 | 
| Fasting Plasma Glucose (FPG) |  | Week 26 | 
| Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. | Week 26 | 
| Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 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. | Week 26 | 
| Incidence of Hypoglycaemic Episodes During the Trial | 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. | Weeks 0-26 | 
| Hypoglycaemic Episodes, Diurnal | 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. | Weeks 0-26 | 
| Hypoglycaemic Episodes, Nocturnal | 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. | Weeks 0-26 | 
| Hypoglycemic Episodes, Unclassifiable | 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. | Weeks 0-26 | 
| Change in Body Weight From Baseline |  | Week 0, Week 26 | 
| Number of Subjects Having the Adverse Event Incorrect Dose Administered | Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications | Weeks 0-26 |