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Trial record 1 of 1 for:    GEMIGL07185
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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

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ClinicalTrials.gov Identifier: NCT02343926
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: GEMIGLIPTIN LS15-0444 Drug: vildagliptin Drug: metformin Phase 3

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gemigliptin
GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin
Drug: GEMIGLIPTIN LS15-0444

Pharmaceutical form:tablet

Route of administration: oral

Other Name: Zemiglo

Drug: metformin

Pharmaceutical form:tablet

Route of administration: oral


Active Comparator: Vildagliptin
Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin
Drug: vildagliptin

Pharmaceutical form:tablet

Route of administration: oral

Other Name: Galvus

Drug: metformin

Pharmaceutical form:tablet

Route of administration: oral





Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Up to Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in fasting plasma glucose [ Time Frame: Up to Week 24 ]
  2. Change from baseline in postprandial glucose [ Time Frame: Up to Week 24 ]
  3. Percentage of patients achieving HbA1c <7% and <6.5% [ Time Frame: Up to Week 24 ]
  4. Percentage of patients with at least one episode of hypoglycemia [ Time Frame: Up to Week 24 ]
  5. Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia) [ Time Frame: Up to Week 24 ]
  6. Change from baseline in body weight [ Time Frame: Up to Week 24 ]
  7. Number of adverse events [ Time Frame: Up to Week 24 ]
  8. Number of serious adverse events [ Time Frame: Up to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343926


Locations
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Russian Federation
Investigational Site 03
Vladimir, Vladimirskaya Oblast, Russian Federation, 600023
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02343926     History of Changes
Other Study ID Numbers: GEMIGL07185
U1111-1165-9138 ( Other Identifier: UTN )
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action