Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

NCT ID: NCT02343926

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-04-30

Brief Summary

Primary Objective:

To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.

Secondary Objectives:

To compare the safety and tolerability of gemigliptin and vildagliptin:

• Number of patients who experience at least one episode of hypoglycemia.
• Number of patients experiencing adverse event (AE), serious adverse event (SAE).
• Assessment of patients compliance defined as number tablets returned by patients.

Detailed Description

The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks).

The protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin.

Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2 (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation) Visit 4: Week 24 (efficacy and safety evaluation)

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemigliptin

GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin

Group Type: EXPERIMENTAL

GEMIGLIPTIN LS15-0444

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

metformin

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

Vildagliptin

Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin

Group Type: ACTIVE_COMPARATOR

vildagliptin

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

metformin

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

Interventions

GEMIGLIPTIN LS15-0444

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type: DRUG

vildagliptin

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type: DRUG

metformin

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

Zemiglo; Galvus

Eligibility Criteria

Inclusion Criteria

• Patients with Type 2 diabetes mellitus.
• Patients inadequately controlled with metformin at the maximal effective and tolerated dose of metformin for at least 12 weeks or who are on a stable dose of ≥1500 mg daily for a minimum of ≥4 weeks prior to study entry.
• Signed informed consent obtained prior to any study procedures.

Exclusion Criteria

• Patients with type 1 diabetes mellitus, gestational diabetes, or diabetes secondary to pancreatic disorders, drug or chemical agent intake.
• Male and female younger than 18 and older than 75 years old.
• Patients with HbA1c ≤7% and ≥9.5%.
• Patients with 20 kg/m^2 > body mass index (BMI) >40 kg/m^2.
• Patients with history of hypersensitivity to metformin.
• Patients with history of hypersensitivity to vildagliptin.
• Lactose intolerance, lactase deficit, glucose-galactose malabsorption.
• Patients who have a history of acute metabolic complications such as lactic acidosis, diabetic pre-coma, diabetic ketoacidosis or hyperosmolar hyperglycemic state within 3 months before study entry.
• Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue.
• Patients who have been treated by thiazolidinediones (pioglitazone) in the last 6 months.
• Use of systemic glucocorticosteroids (excluding topical application or inhaled forms) for 7 consecutive days or within more than 3 months prior to study entry.
• Patients with impaired hepatic function (alanine transaminase [ALT], aspartate transaminase [AST] activity >1.5 times the upper limit of normal [ULN]).
• Patients with impaired renal function (serum creatinine concentration >135ɥmol/l in men and >110ɥmol/l in female).
• Patients who had experienced myocardial infarction, stroke, unstable angina or coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment.
• Patients with chronic heart failure II-IV functional class according to the classification of NYHA (New York Heart Association).
• Patients taking medicines of thyroid hormones, warfarin, dicoumarin or digoxin.
• Patients who took sodium channel blockers and SGLT2 inhibitors (or inhibitors sodium glucose transporters 2) in the last 6 weeks prior to study entry.
• Known history of alcohol or drug abuse within 6 months prior to screening.
• Pregnant or woman during breast feeding period.
• Women of childbearing potential not protected by effective contraceptive method of birth control.
• Men whose partners are planning pregnancy.
• History of hypersensitivity to the study drug or to a drug with a similar chemical structure.
• Use of any investigational drug within 3 months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site 03

Vladimir, Vladimirskaya Oblast’, Russia

Countries

Russia

Other Identifiers

U1111-1165-9138

Identifier Type: OTHER

Identifier Source: secondary_id

GEMIGL07185

Identifier Type: -

Identifier Source: org_study_id