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Clinical Trials/CTRI/2009/091/001036
CTRI/2009/091/001036
Completed
Phase 3

Efficacy and safety of Hydroxychloroquine in the Treatment of Type II Diabetes Mellitus: A Double Blind, Randomized Comparison with Pioglitazone

Ipca Laboratories Limited0 sites267 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Ipca Laboratories Limited
Enrollment
267
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients diagnosed of type II diabetes defined by ADA criteria and are uncontrolled by combination therapy of two oral hypoglycemic agents i.e. either metformin greater than or equal to 1000mg/day in combination with glimepiride greater than or equal to 4mg/day or gliclazide greater than or equal to 160mg/day combination
  • •3\. Patients with HbA1c greater than or equal to 7\.5 % and less than or equal to 11\.5 % at baseline visit (HbA1C 7\.5 % and less than or equal to 11\.5 % for screening visit)
  • •4\. Patients with body weight greater than or equal to 60 kg
  • •5\. Patients willing and likely to fully comply with study procedures and restrictions and ready to give written informed consent

Exclusion Criteria

  • •1\. Patients with other than Type II diabetes
  • •2\. Patients with a history of any retinopathy including diabetic retinopathy
  • •3\. Patients with abnormal renal and liver function.
  • •4\. Patients with disease of blood or haematopoetic organs
  • •5\. Patient with known history of diabetic ketoacidosis
  • •6\. Patients receiving insulin therapy
  • •7\. Patients with known history of hypersensitivity to hydroxychloroquine, glimepiride, gliclazide, metformin , pioglitazone or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of severe allergic disease
  • •8\. Pregnant or lactating women.
  • •9\. Women of childbearing potential not practicing contraception.

Outcomes

Primary Outcomes

Not specified

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