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

NCT02343926 | Completed Phase 3

• 2 other identifiers: GEMIGL07185U1111-1165-9138
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  Up to Week 24

Secondary Outcomes (8)

• Change from baseline in fasting plasma glucose

  Up to Week 24

• Change from baseline in postprandial glucose

  Up to Week 24

• Percentage of patients achieving HbA1c <7% and <6.5%

  Up to Week 24

• Percentage of patients with at least one episode of hypoglycemia

  Up to Week 24

• Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)

  Up to Week 24

Study Arms (2)

Gemigliptin

EXPERIMENTAL

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

Drug: GEMIGLIPTIN LS15-0444; Drug: metformin

Vildagliptin

ACTIVE COMPARATOR

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

Drug: vildagliptin; Drug: metformin

Interventions

GEMIGLIPTIN LS15-0444 DRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: Zemiglo

Gemigliptin

vildagliptin DRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: Galvus

Vildagliptin

metformin DRUG

Pharmaceutical form:tablet Route of administration: oral

Gemigliptin; Vildagliptin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site 03

Vladimir, Vladimirskaya Oblast’, 600023, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

RU (1)