Phase 4
Completed N=46
A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)
Source: ClinicalTrials.gov NCT01868542 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Jun 2016
Primary outcomePrimary: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline. — -0.9; -1.0 Percent (%) glycosylated haemoglobin
Summary
This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other anti-diabetic drugs (OADs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline. |
-0.9; -1.0 | — |
| SECONDARY Change in HbA1c |
-0.8; -0.9 | — |
| SECONDARY Proportion of Subjects Achieving HbA1c Below 7.0% |
8.7; 14.3; 91.3; 85.7 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline |
-60.4; -70.0 | — |
| SECONDARY Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours. |
72; 119; 22; 17 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline |
-60.4; -70.0 | — |
| SECONDARY Incidence of Adverse Events |
24; 29; 0; 1; 24; 28 | — |
Eligibility Criteria
Inclusion Criteria
- - Diagnosed with type 2 diabetes mellitus at least 3 months prior to Visit 1 (week -2)
- - Treatment with at least 1000 mg metformin per day with/without other OADs at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to Visit 1
- - Insulin-naïve subjects
- - HbA1c above or equal to 7.5% by central laboratory analysis
- - Body mass index (BMI) below or equal to 35.0 kg/m^2
Exclusion Criteria
- - Female who is breast-feeding
- - The receipt of any investigational product within 4 weeks prior to Visit 1
- - Any contraindication to insulin detemir according to the domestic labelling
- - Anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase [MAO] inhibitors)
- - 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 conditions that the investigator judges would interfere with trial participation or evaluation of the results
Data sourced from ClinicalTrials.gov (NCT01868542). 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.