Phase 4
Completed N=156
Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients
Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT02002221 ↗
Enrolled (actual)
156
Serious AEs
1.9%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups — -1.01; -0.11 percentage of glycosylated haemoglobin — p=< 0.001
Summary
The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups |
-1.01; -0.11 | < 0.001 sig |
| SECONDARY Percentage of Patients Meeting Responder Rates in HbA1c |
67; 21; 23; 2; 38; 3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks |
-21.87; -0.30 | — |
| SECONDARY Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia |
5; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Death |
36; 34; 2; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of T2DM by standard criteria.
- HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
- Age: ≥ 20 to < 75 years old at Visit 1.
- BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.
Exclusion Criteria
- FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
- Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
- Significant heart diseases
- Hepatic disorder
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02002221). 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.