Phase 3
Completed N=171
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
Source: ClinicalTrials.gov NCT01811485 ↗Enrolled (actual)
171
Serious AEs
1.4%
Results posted
Feb 2015
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups — -0.83; 0.14 percentage of glycosylated haemoglobin
Summary
The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups |
-0.83; 0.14 | — |
| SECONDARY Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups |
-0.61; -1.04 | — |
| SECONDARY Percentage of Patients Meeting Responder Rates in HbA1c |
27.8; 0.0; 45.8; 13.5; 66.7; 18.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks |
-13.02; 16.54 | — |
| SECONDARY Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death |
25; 25; 38; 0; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range of 20-35 kg/m^2
Exclusion Criteria
- Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01811485). 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.