Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Overview[ - collapse ][ - ]
Purpose | Primary Objective: - To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: - To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on: - Percentage of patients reaching HbA1c < 7% - Percentage of patients reaching HbA1c < 6.5% - Fasting Plasma Glucose (FPG) - Safety and tolerability |
---|---|
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: GLIMEPIRIDE Drug: METFORMIN |
Phase | Phase 3 |
Sponsor | Sanofi |
Responsible Party | Sanofi |
ClinicalTrials.gov Identifier | NCT01459809 |
First Received | October 24, 2011 |
Last Updated | February 4, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 24, 2011 |
---|---|
Last Updated Date | February 4, 2014 |
Start Date | February 2012 |
Estimated Primary Completion Date | January 2014 |
Current Primary Outcome Measures | Change in HbA1c [Time Frame: from baseline to week 24] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients |
---|---|
Official Title | A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes |
Brief Summary | Primary Objective: - To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: - To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on: - Percentage of patients reaching HbA1c < 7% - Percentage of patients reaching HbA1c < 6.5% - Fasting Plasma Glucose (FPG) - Safety and tolerability |
Detailed Description | The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: GLIMEPIRIDE Pharmaceutical form: oral Route of administration: oral Other Names: HOE490Drug: METFORMIN Pharmaceutical form: oral Route of administration: oral |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 542 |
Estimated Completion Date | January 2014 |
Estimated Primary Completion Date | January 2014 |
Eligibility Criteria | Inclusion criteria - Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit - Signed informed consent, obtained prior to any study procedure Exclusion criteria - Age < 18 and => 78 years old - HbA1c < 7.6% or > 9% - BMI > 35 kg/m2 - Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...) - Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Algeria, Colombia, Egypt, Guatemala, India, Iran, Islamic Republic of, Lebanon, Mexico, Russian Federation, Saudi Arabia, South Africa, Tunisia, Turkey, Ukraine, United Arab Emirates |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01459809 |
---|---|
Other Study ID Numbers | GLIME_R_05809 |
Has Data Monitoring Committee | Yes |
Information Provided By | Sanofi |
Study Sponsor | Sanofi |
Collaborators | Not Provided |
Investigators | Study Director: Clinical Sciences & Operations Sanofi |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Investigational Site Number 01206 | Algeries, Algeria |
---|---|
Investigational Site Number 01201 | Algiers, Algeria, 16000 |
Investigational Site Number 01202 | Algiers, Algeria |
Investigational Site Number 01203 | Oran, Algeria, 31000 |
Investigational Site Number 01205 | Setif, Algeria, 19000 |
Investigational Site Number 17003 | El Espinal, Colombia |
Investigational Site Number 170001 | Manizales, Colombia, 170 |
Investigational Site Number 170002 | Pereira, Colombia, 170 |
Investigational Site Number 81801 | Cairo, Egypt |
Investigational Site Number 81803 | Cairo, Egypt |
Investigational Site Number 32002 | Guatemala, Guatemala |
Investigational Site Number 32003 | Guatemala, Guatemala |
Investigational Site Number 32004 | Guatemala, Guatemala |
Investigational Site Number 32001 | Guatemala, Guatemala |
Investigational Site Number 356001 | Bangalore, India, 560043 |
Investigational Site Number 356002 | Bangalore, India, 560052 |
Investigational Site Number 356006 | Ernakulam, India |
Investigational Site Number 356003 | Indore, India, 452010 |
Investigational Site Number 356004 | Kolkata, India, 700054 |
Investigational Site Number 356009 | Lucknow, India, 226003 |
Investigational Site Number 356010 | Mumbai, India |
Investigational Site Number 356007 | Nashik, India, 422002 |
Investigational Site Number 356008 | Pune, India, 411007 |
Investigational Site Number 356005 | Varanasi, India |
Investigational Site Number 364001 | Tehran, Iran, Islamic Republic of, 1411413137 |
Investigational Site Number 364002 | Tehran, Iran, Islamic Republic of, 1666694516 |
Investigational Site Number 36403 | Tehran, Iran, Islamic Republic of |
Investigational Site Number 42202 | Beirut, Lebanon |
Investigational Site Number 42201 | Beirut, Lebanon |
Investigational Site Number 42203 | Chouf, Lebanon |
Investigational Site Number 422004 | Hazmieh, Lebanon |
Investigational Site Number 484002 | Guadalajara, Mexico, 44340 |
Investigational Site Number 484003 | Guadalajara, Mexico, 44670 |
Investigational Site Number 643003 | Moscow, Russian Federation, 119002 |
Investigational Site Number 643002 | Saratov, Russian Federation, 410012 |
Investigational Site Number 643001 | St.-Petersburg, Russian Federation |
Investigational Site Number 01 | Dammam, Saudi Arabia, 31444 |
Investigational Site Number 710-003 | Bloemfontein, South Africa, 9301 |
Investigational Site Number 710-002 | Durban, South Africa, 4091 |
Investigational Site Number 710-001 | Durban, South Africa, 4092 |
Investigational Site Number 710-005 | Pretoiria, South Africa |
Investigational Site Number 78804 | La Marsa, Tunisia, 2070 |
Investigational Site Number 78803 | La Marsa, Tunisia, 2070 |
Investigational Site Number 78805 | Sfax, Tunisia |
Investigational Site Number 78802 | Tunis, Tunisia |
Investigational Site Number 78801 | Tunis, Tunisia |
Investigational Site Number 78806 | Tunis, Tunisia |
Investigational Site Number 78807 | Tunis, Tunisia |
Investigational Site Number 792-004 | Adana, Turkey |
Investigational Site Number 792-003 | Antalya, Turkey, 07070 |
Investigational Site Number 792-001 | Istanbul, Turkey, 34722 |
Investigational Site Number 792-006 | Istanbul, Turkey, 34890 |
Investigational Site Number 792-002 | Kutahya, Turkey |
Investigational Site Number 792-005 | Sivas, Turkey, 58140 |
Investigational Site Number 804001 | Kyiv, Ukraine, 02175 |
Investigational Site Number 804002 | Kyiv, Ukraine, 04114 |
Investigational Site Number 804003 | Zaporozhye, Ukraine |
Investigational Site Number 784-001 | Dubai, United Arab Emirates |
Investigational Site Number 784-003 | Dubai, United Arab Emirates |
Investigational Site Number 784-002 | Dubai, United Arab Emirates |
Investigational Site Number 784-004 | Sharjah, United Arab Emirates, 46458 |