A clinical trial to study the effects of two drugs,metformin and Alpha Lipoic Acid combination in patients of Diabetic polyneuropathy.

Phase 3

Completed

• Registration Number: CTRI/2009/091/000714
• Lead Sponsor: M/S JENBURKT PHARMACEUTICALS LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

All patients with duly filled in ICFs [Informed Consent Forms]
Ages: Eligible for Study: 18 - 60Years,
Genders Eligible for Study: Both
BMI ? Patients having BMI from 18-27%
Patients with Type 2 Diabetes in whom Diabetes was inadequately controlled by diet alone.
Fasting serum insulin < 15&#956;IU/ mL and peak serum Insulin during Patients with HbA1clevel was >7 and <12%.
Patients with fasting serum c-peptide of 0.333 pmol/ L.
Patients with fasting serum glucose-to-insulin ration of > 4.5mg &#956;IU/ mL.dL
Patients who were taking Sulfonylurea or Metformin below the maximum dose as long as the antidiabetic drug was discontinued.

Exclusion Criteria

Patients unwilling to sign on ICF.
Patients with known history of sensitivity to ALA or Metformin.
Patients with a history of lactic acidosis.
Patients having received other investigational drugs within 2 weeks of therapy,
Patients having received insulin treatment 30-days prior to the enrollment in the study.
Patients having received glucocorticoid therapy within 4 weeks of therapy.
Women using oral contraceptives that can affect insulin sensitivity
Patients with Type 1 Diabetes.
Patients having BMI > 27
Patients with HbA1clevel was >12%
Patients with major debilitating diseases.
Patients with recent cardiovascular events.
Patients with gastrointestinal diseases.
Patients with significant renal impairment (blood urea nitrogen, >35 mg/dl; serum creatinine, >2.0 mg/dl; or creatinine clearance, <40 ml/min per 1.73 m2 of body surface area),
Patients with severe hepatic disease.
Pregnancy or breast-feeding.
Any other serious diseases having fatal progression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified