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NCT00820573 · ClinicalTrials.gov registry record · Phase 4

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM

A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
Phase 4
Development phase
16
Enrollment target

NCT00820573: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.

NCT00820573 is a Phase 4 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00820573, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
Phase 4
Development phase
16 participants
Enrollment target

Study Summary

In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment: Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on hepatic glucose production (HGP). Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin provides greater reduction in hepatic glucose production (HGP) compared to placebo.

Primary Outcome

Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants

Interventions

  • DRUG Placebo
  • DRUG Metformin
  • DRUG Sitagliptin
  • DRUG Sitagliptin + Metformin

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2009-10
Est. Completion 2012-10
Phase Phase 4

What the finished NCT00820573 record still lists

NCT00820573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00820573 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00820573 about?

NCT00820573 is a clinical study titled "Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM". In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment: Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on hepatic glucose production (HGP). Hypothesis: After 6 weeks of treatment, the...

What is the current status of trial NCT00820573?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2009-10. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00820573?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Sitagliptin (DRUG), Sitagliptin + Metformin (DRUG).

Who is sponsoring clinical trial NCT00820573?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00820573's enrollment target sits among peer trials

16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00820573, the US trial registry maintained by the National Library of Medicine. NCT00820573 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.