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

AN OPEN LABELED, DOUBLE ARM, RANDOMIZED, MULTICENTRIC, PROSPECTIVE, PHASE-III TRIAL TO COMPARE THE EFFICACY, TOLERABILITY AND SAFETY OF FIXED DOSE COMBINATION OF ALPHA-LIPOIC ACID AND METFORMIN WITH METFORMIN ALONE IN THE TREATMENT OF PATIENTS OF DIABETIC POLYNEUROPATHY.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000714

Enrollment

200

Registered

2010-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Metformin HCl 500 mg+ Alpha Lipoic Acid 200 mg: One tablet two times a day. Control Intervention1: Metformin 500 mg: One tablet two times a day.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The clinical response to therapy will be considered satisfactory if, at the end of therapy, there will change in HbA1c level from baseline to the end of the double-blind treatment for the intent-to-treat (ITT) population, which included any patient who had both a baseline value and at least one postrandomization ef&#64257;cacy value. Secondary ef&#64257;cacy parameters included the change in fasting plasma glucose and serum insulin levels and serum triglyceride levels from baseline to the end of treatment. Timepoint: 2 months	—

Measure

Time frame

The clinical response to therapy will be considered satisfactory if, at the end of therapy, there will change in HbA1c level from baseline to the end of the double-blind treatment for the intent-to-treat (ITT) population, which included any patient who had both a baseline value and at least one postrandomization ef&#64257;cacy value. Secondary ef&#64257;cacy parameters included the change in fasting plasma glucose and serum insulin levels and serum triglyceride levels from baseline to the end of treatment. Timepoint: 2 months

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr. Nitin M Rathod

nitinmr@yahoo.in

Outcome results