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NCT00678080 · ClinicalTrials.gov registry record · NA

Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

A NA study, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT00678080: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.

NCT00678080 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00678080, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

Primary Outcome

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

Interventions

  • DRUG Metformin
  • DRUG Insulin (NPH and Regular)

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2008-09
Est. Completion 2011-08
Phase NA

What the finished NCT00678080 record still lists

NCT00678080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.

NCT00678080 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00678080 about?

NCT00678080 is a clinical study titled "Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes". Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar co...

What is the current status of trial NCT00678080?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2008-09. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00678080?

The interventions under investigation include: Metformin (DRUG), Insulin (NPH and Regular) (DRUG).

Who is sponsoring clinical trial NCT00678080?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00678080's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00678080, the US trial registry maintained by the National Library of Medicine. NCT00678080 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.