Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: Placebo; Drug: Vildagliptin (LAF237); Drug: Insulin; Drug: Metformin

• Registration Number: NCT02002221
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-11-29
• Study Start: 2013-12
• Study First Posted: 2013-12-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-01
• Results First Submitted: 2016-02-02
• Results First Submitted QC: 2016-02-02
• Last Update Submitted: 2016-02-02
• Results First Posted: 2016-03-01
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin (LAF237)	Insulin	Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Placebo	Placebo	In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Placebo	Insulin	In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Vildagliptin (LAF237)	Vildagliptin (LAF237)	Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Placebo	Metformin	In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Vildagliptin (LAF237)	Metformin	Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups	Baseline, week 12	HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Meeting Responder Rates in HbA1c	Baseline, week 12	Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c \< 7% , Criterion 3- Endpoint HbA1c \< 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (\> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.
Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia	12 weeks	Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is \< 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is \< 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)
Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks	Baseline, week 12	FPG was performed on a blood sample obtained and analyzed at a central laboratory.
Number of Participants With Adverse Events, Serious Adverse Events and Death	12 weeks	The occurrence of adverse events was 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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Suginami-ku, Tokyo, Japan