Clinical trial NCT02343926: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Up to Week 24
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: Up to Week 24
measure: Change from baseline in postprandial glucose
timeFrame: Up to Week 24
measure: Percentage of patients achieving HbA1c <7% and <6.5%
timeFrame: Up to Week 24
measure: Percentage of patients with at least one episode of hypoglycemia
timeFrame: Up to Week 24
measure: Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)
timeFrame: Up to Week 24
measure: Change from baseline in body weight
timeFrame: Up to Week 24
measure: Number of adverse events
timeFrame: Up to Week 24
measure: Number of serious adverse events
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Vladimir
country: Russian Federation
facility: Investigational Site 03
state: Vladimirskaya Oblast
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: