Phase 3
Completed N=222
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00789191 ↗Enrolled (actual)
222
Serious AEs
2.8%
Results posted
Dec 2010
Primary outcomePrimary: HbA1c (Glycosylated Haemoglobin A1c) — 7.08; 7.64 Percent (%) glycosylated haemoglobin — p=0.0010
Summary
This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c (Glycosylated Haemoglobin A1c) |
7.08; 7.64 | 0.0010 sig |
| SECONDARY Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% |
46; 25; 57; 81 | 0.0010 sig |
| SECONDARY Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia |
37; 21; 66; 85 | 0.0080 sig |
| SECONDARY Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% |
20; 11; 83; 95 | 0.063 |
| SECONDARY Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia |
15; 8; 88; 98 | 0.135 |
| SECONDARY Change in BMI (Body Mass Index) |
-0.30; -0.58 | 0.121 |
| SECONDARY Change in Body Weight |
-0.81; -1.66 | 0.109 |
| SECONDARY FPG (Fasting Plasma Glucose) |
6.08; 8.52 | 0.0010 sig |
| SECONDARY Hypoglycemic Episodes |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Hypoglycemic Episodes: Day Time |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Hypoglycemic Episodes: Night Time |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Self-measured 9-point Plasma Glucose Profile |
6.16; 8.17; 8.82; 10.50; 6.99; 8.01 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes for at least 6 months before trial start
- Treatment with at least 1000 mg metformin per day for at least 3 months
- Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
- DPP-4 (dipeptidyl peptidase-4) inhibitor naive
- HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
- BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
- Able and willing to take one subcutaneous injection every day
- Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements
Exclusion Criteria
- Known or suspected allergy or intolerance to any of the trial products or related products
- Severe hypertension
- Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
- Cardiac disease, within the last 12 months
- Impaired hepatic function
- Impaired renal function
- Proliferative retinopathy or macular oedema requiring acute treatment
- Female of childbearing potential
- Known or suspected abuse of alcohol, narcotics or illicit substances
Data sourced from ClinicalTrials.gov (NCT00789191). 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.