Study of efficacy and safety of Vildagliptin as add-on insulin therapy in T2DM patients

A 12-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of Equa (vildagliptin) 50 mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080222358

Enrollment

152

Registered

2014-01-07

Start date

2014-01-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

investigational material(s) Generic name etc : LAF237(vildagliptin) INN of investigational material : vildagliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Confirmed diagnosis of T2DM by standard criteria. *HbA1c >= 7.0 to = 20 to = 20 to <= 35 kg/m2 at Visit 1.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups [Time Frame: Baseline to 12 weeks] HbA1c will be performed on a blood sample obtained and measured by HPLC performed at a central laboratory.	—

Secondary

Measure	Time frame
Percentage of patients meeting Responder rates in HbA1c [Time Frame: Baseline, at 12 weeks] Responder rates will be analyzed in categories: a. Endpoint HbA1c = 1%, e. HbA1c reduction from baseline at endpoint >= 0.5% Change from baseline in Fasting plasma glucose (FPG) at 12 weeks [Time Frame: Baseline to 12 weeks] FPG will be performed on a blood sample obtained and analyzed at a central laboratory. Number of participants with hypoglycemia and severe hypoglycemia [Time Frame: 12 weeks] Symptoms consistent with hypoglycemia and confirmed by plasma glucose < 56 mg/dL Number of patients with adverse events, serious adverse events and death [Time Frame: 12 weeks] The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.	—

Measure

Time frame

Percentage of patients meeting Responder rates in HbA1c [Time Frame: Baseline, at 12 weeks] Responder rates will be analyzed in categories: a. Endpoint HbA1c = 1%, e. HbA1c reduction from baseline at endpoint >= 0.5% Change from baseline in Fasting plasma glucose (FPG) at 12 weeks [Time Frame: Baseline to 12 weeks] FPG will be performed on a blood sample obtained and analyzed at a central laboratory. Number of participants with hypoglycemia and severe hypoglycemia [Time Frame: 12 weeks] Symptoms consistent with hypoglycemia and confirmed by plasma glucose < 56 mg/dL Number of patients with adverse events, serious adverse events and death [Time Frame: 12 weeks] The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026