Clinical trial NCT01204580: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
timeFrame: from baseline to end of Clinical Trial (12 weeks)
Secondary outcomes:
measure: Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels
timeFrame: at week 8
measure: Pulse Wave Velocity (PWV) change
timeFrame: at week 8 and week 12
measure: Change in Fasting Blood Glucose (FBG)
timeFrame: At week 2, 4, 8 and 12
measure: Change in glycosylated hemoglobin (HbA1c)
timeFrame: at week 12
measure: Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)
timeFrame: At week 12
measure: Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)
timeFrame: At week 12
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: