ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination | RxWiki

ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination

Overview[ - collapse ][ - ]

Purpose	Primary Objective: To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M Secondary Objectives: 1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy 2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M 3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c)) 4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M 5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M 6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M 7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: GLIMEPIRIDE + METFORMIN
Phase	Phase 4
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT01204580
First Received	September 16, 2010
Last Updated	April 2, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	September 16, 2010
Last Updated Date	April 2, 2012
Start Date	December 2010
Estimated Primary Completion Date	March 2012
Current Primary Outcome Measures	Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes [Time Frame: from baseline to end of Clinical Trial (12 weeks)] [Designated as safety issue: No]
Current Secondary Outcome Measures	Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels [Time Frame: at week 8] [Designated as safety issue: No] Pulse Wave Velocity (PWV) change [Time Frame: at week 8 and week 12] [Designated as safety issue: No] Change in Fasting Blood Glucose (FBG) [Time Frame: At week 2, 4, 8 and 12] [Designated as safety issue: No] Change in glycosylated hemoglobin (HbA1c) [Time Frame: at week 12] [Designated as safety issue: No] Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β) [Time Frame: At week 12] [Designated as safety issue: No] Change of Tumor Necrosis Factor- Alfa (TNF-Alfa) [Time Frame: At week 12] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination
Official Title	ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)
Brief Summary	Primary Objective: To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M Secondary Objectives: 1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy 2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M 3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c)) 4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M 5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M 6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M 7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
Detailed Description	The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: GLIMEPIRIDE + METFORMIN Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day Other Names: Amaryl-M
Study Arm (s)	Experimental: Amaryl-M (Glimepiride + Metformin) Glimepiride 1 mg and metformin 250 mg are the active ingredients of Amaryl-M 1/250 mg film coated tablets. Starting dosage is 1 tablet per day, then dosage titration will be based on the result of patient FBG test.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	40
Estimated Completion Date	March 2012
Estimated Primary Completion Date	March 2012
Eligibility Criteria	Inclusion criteria: - Type 2 diabetes mellitus patients - Patients with HbA1c >or= 7.0% and < 10.0% - Patients not currently treated with any oral antidiabetic drugs (OADs) Exclusion criteria: - Participation in other investigational Clinical Trial - Current temporary insulin treatment: gestational diabetes, pancreas cancer, surgery etc. - Women who are pregnant and lactating - Type 1 diabetes mellitus patients - Treatment with antihypertensive Angiotensin-Converting Enzyme (ACE)-Inhibitors and/or Angiotensin II Receptor Blocker (ARB) or has just stopped treatment for less than two months - Treatment with lipid lowering agent statins or has just stopped treatment for less than two months - Known hypersensitive to any of the excipients of Amaryl-M, sulphonylureas, sulfonamides or biguanide - Patients with active smoking or history of smoking cessation less than 2 months - Patients with history of severe hepatic dysfunction - Patients with serum creatinine >or= 1.5 mg/dL (male) and >or= 1.4 mg/dL (female) - Patients with congestive heart failure requiring pharmacologic treatment - Treatment with antifungal agent especially Miconazole The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender	Both
Ages	40 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Indonesia

Administrative Information[ + expand ][ + ]

NCT Number	NCT01204580
Other Study ID Numbers	GLMET_L_04735
Has Data Monitoring Committee	Not Provided
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Clinical Sciences & Operations Sanofi
Verification Date	April 2012

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