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pantoprazole in the treatment of type 2 diabetes mellitus

Phase 2
Completed
Conditions
Health Condition 1: null- Type 2 Diabetic patient without any complication
Registration Number
CTRI/2011/07/001899
Lead Sponsor
PGIMER
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

?Type-2 DM 5 years duration

?On oral antidiabetic therapy ( Metformin±Sulfonylurea)

?No change in anti-diabetic treatment for the last one month

?HbA1c 8.5%

?Fasting plasma glucose not exceeding 300mg/dL

?Patients willing to provide written informed consent

Exclusion Criteria

?Diabetes other than type 2 diabetes mellitus

?Evidence of renal disease (S. creatinine 1.5mg/ml)

? Evidence of liver disease (AST/ALT 3 times normal)

? Pregnant and lactating mothers and women intending pregnancy

?Participation in any other clinical trial with in the last 30 days

?History of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin

?Treatment with oral anti-diabetic agents (other than metformin or SU) during the 12 weeks before baseline visit

?History of intolerance or hypersensitivity to sulfonylurea or metformin or PPI

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effect of pantoprazole on HbA1c levelTimepoint: 0 and 3 months
Secondary Outcome Measures
NameTimeMethod
Effect of pantoprazole on 1.FBG, PPBG, HOMA-IR and Beta-cell function <br/ ><br>2.Serum Gasrin level <br/ ><br>3.Serum GLP-1level <br/ ><br>4.Serum Insulin level <br/ ><br>5.Serum C-peptide levelTimepoint: 0 and 3 months
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