Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients (RECOMMEND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01459809
First received: October 24, 2011
Last updated: February 4, 2014
Last verified: February 2014
  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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: GLIMEPIRIDE
Drug: METFORMIN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with HbA1c < 7% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c < 6.5 % [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: from baseline week 24 ] [ Designated as safety issue: No ]
  • Number of patients reporting adverse events [ Time Frame: overt the 24-weeks treatment period ] [ Designated as safety issue: Yes ]
  • Frequence and incidence of hypoglycemia [ Time Frame: over the 24-weeks treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 542
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM 1: glimepiride alone
24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline < 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.
Drug: GLIMEPIRIDE

Pharmaceutical form: oral

Route of administration: oral

Other Name: HOE490
Experimental: ARM 2: metformin alone
24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.
Drug: METFORMIN

Pharmaceutical form: oral

Route of administration: oral

Experimental: ARM3: Glimepiride/metformin free combination
24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline < 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤.
Drug: GLIMEPIRIDE

Pharmaceutical form: oral

Route of administration: oral

Other Name: HOE490
Drug: METFORMIN

Pharmaceutical form: oral

Route of administration: oral


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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459809

  Hide Study Locations
Locations
Algeria
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
Colombia
Investigational Site Number 17003
El Espinal, Colombia
Investigational Site Number 170001
Manizales, Colombia, 170
Investigational Site Number 170002
Pereira, Colombia, 170
Egypt
Investigational Site Number 81801
Cairo, Egypt
Investigational Site Number 81803
Cairo, Egypt
Guatemala
Investigational Site Number 32001
Guatemala, Guatemala
Investigational Site Number 32003
Guatemala, Guatemala
Investigational Site Number 32004
Guatemala, Guatemala
Investigational Site Number 32002
Guatemala, Guatemala
India
Investigational Site Number 356002
Bangalore, India, 560052
Investigational Site Number 356001
Bangalore, India, 560043
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
Iran, Islamic Republic of
Investigational Site Number 364001
Tehran, Iran, Islamic Republic of, 1411413137
Investigational Site Number 36403
Tehran, Iran, Islamic Republic of
Investigational Site Number 364002
Tehran, Iran, Islamic Republic of, 1666694516
Lebanon
Investigational Site Number 42201
Beirut, Lebanon
Investigational Site Number 42202
Beirut, Lebanon
Investigational Site Number 42203
Chouf, Lebanon
Investigational Site Number 422004
Hazmieh, Lebanon
Mexico
Investigational Site Number 484003
Guadalajara, Mexico, 44670
Investigational Site Number 484002
Guadalajara, Mexico, 44340
Russian Federation
Investigational Site Number 643003
Moscow, Russian Federation, 119002
Investigational Site Number 643002
Saratov, Russian Federation, 410012
Investigational Site Number 643001
St.-Petersburg, Russian Federation
Saudi Arabia
Investigational Site Number 01
Dammam, Saudi Arabia, 31444
South Africa
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
Tunisia
Investigational Site Number 78803
La Marsa, Tunisia, 2070
Investigational Site Number 78804
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
Turkey
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
Ukraine
Investigational Site Number 804002
Kyiv, Ukraine, 04114
Investigational Site Number 804001
Kyiv, Ukraine, 02175
Investigational Site Number 804003
Zaporozhye, Ukraine
United Arab Emirates
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
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01459809     History of Changes
Other Study ID Numbers: GLIME_R_05809, U1111-1119-9984
Study First Received: October 24, 2011
Last Updated: February 4, 2014
Health Authority: Guatemala: Ministry of Public Health and Social Assistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Metformin
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014