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pantoprazole in the treatment of type 2 diabetes mellitus

Evaluation of Pantoprazole (PPI) on Glucose - Insulin homeostasis in patients with Type-2 Diabetes Mellitus: A Randomized Double Blind Placebo Controlled (Proof of Concept) Study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001899
Enrollment
30
Registered
2011-07-19
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

Health Condition 1: null- Type 2 Diabetic patient without any complication

Interventions

Intervention1: Pantoprazole and metformin with/without sulfonylurea: Pantoprazole 40 mg bd for 3 months alongwith appropriate doses of metformin with or without sulfonylurea Control Intervention1: Mat

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Effect of pantoprazole on HbA1c levelTimepoint: 0 and 3 months

Secondary

MeasureTime frame
Effect of pantoprazole on 1.FBG, PPBG, HOMA-IR and Beta-cell function 2.Serum Gasrin level 3.Serum GLP-1level 4.Serum Insulin level 5.Serum C-peptide levelTimepoint: 0 and 3 months

Countries

India

Contacts

Public ContactDr Debashish Hota

PGIMER

drpawanpgi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026