Phase 3
Completed N=42
Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT01871558 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms — 22.2; 45.0 percent of participants — p=0.139
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms |
22.2; 45.0 | 0.139 |
| SECONDARY Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events |
44.4; 47.4 | — |
| SECONDARY Change From Baseline in HbA1c to Week 24 in Both Treatment Arms |
8.2; 8.2; 7.2; 7.4 | — |
| SECONDARY Change From Baseline in Body Weight in Both Treatment Arms |
-0.3; 1.4 | — |
| SECONDARY Mean Daily Insulin Dose at Week 24 |
33.0; 19.8 | — |
| SECONDARY Percentage of Patients With Severe and Confirmed Hypoglycemic Events |
0.0; 0.0 | — |
| SECONDARY Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline) |
27.8; 21.1 | — |
Eligibility Criteria
Inclusion Criteria
- T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken
- with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
- with a glycemic target of HbA1c 7% and <=9%
- Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)
Exclusion Criteria
- contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin
- acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01871558). 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.