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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicentre, National, Randomized, Parallel-group, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343926
• Other study ID #: GEMIGL07185
• Secondary ID: U1111-1165-9138
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2015
• Last updated: May 17, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 >135?mol/l in men and >110?mol/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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• GEMIGLIPTIN LS15-0444
Pharmaceutical form:tablet Route of administration: oral
• vildagliptin
Pharmaceutical form:tablet Route of administration: oral
• metformin
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Russian Federation	Investigational Site 03	Vladimir	Vladimirskaya Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		Up to Week 24	No
Secondary	Change from baseline in fasting plasma glucose		Up to Week 24	No
Secondary	Change from baseline in postprandial glucose		Up to Week 24	No
Secondary	Percentage of patients achieving HbA1c <7% and <6.5%		Up to Week 24	No
Secondary	Percentage of patients with at least one episode of hypoglycemia		Up to Week 24	Yes
Secondary	Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)		Up to Week 24	Yes
Secondary	Change from baseline in body weight		Up to Week 24	No
Secondary	Number of adverse events		Up to Week 24	Yes
Secondary	Number of serious adverse events		Up to Week 24	Yes