Phase 4
Completed N=457
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00909480 ↗Enrolled (actual)
457
Serious AEs
4.2%
Results posted
Sep 2011
Primary outcomePrimary: Change in HbA1c From Baseline — -0.48; -0.74 percentage point change
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline |
-0.48; -0.74 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% |
55; 70; 40; 40; 31; 47 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia |
48; 52; 33; 33; 25; 33 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% |
22; 30; 13; 13; 5; 17 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia |
22; 21; 7; 13; 3; 13 | — |
| SECONDARY Fasting Plasma Glucose (FPG) |
6.22; 6.09 | — |
| SECONDARY Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast |
0.48; 0.67; 0.72; 0.84; 0.6; 0.71 | — |
| SECONDARY Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) |
5.8; 5.9; 9.1; 8.7; 7.2; 6.6 | — |
| SECONDARY Incidence of Hypoglycaemic Episodes During the Trial |
329; 457; 0; 2; 119; 156 | — |
| SECONDARY Hypoglycaemic Episodes, Diurnal |
0; 2; 75; 118; 128; 222 | — |
| SECONDARY Hypoglycaemic Episodes, Nocturnal |
0; 0; 39; 30; 76; 61 | — |
| SECONDARY Hypoglycemic Episodes, Unclassifiable |
0; 0; 5; 8; 6; 16 | — |
| SECONDARY Change in Body Weight From Baseline |
-0.49; 1 | — |
| SECONDARY Number of Subjects Having the Adverse Event "Incorrect Dose Administered" |
12; 24 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00909480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.