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NCT01258075 · ClinicalTrials.gov registry record · Phase 4

Colesevelam for Children With Type 2 Diabetes

A Phase 4 study of Type 2 Diabetes Mellitus, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 4
Development phase
236
Enrollment target
20
Study locations

NCT01258075 is a Phase 4 study of Type 2 Diabetes Mellitus that has completed, run by Daiichi Sankyo. The registered enrollment target is 236 participants, below the 2,746-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01258075, a Phase 4 study of Type 2 Diabetes Mellitus, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 4
Development phase
236 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group. We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.

Conditions Studied

Type 2 Diabetes Mellitus

Interventions

  • DRUG High-dose colesevelam
  • DRUG Low-dose colesevelam

Study Locations (20)

California

  • - Los Angeles
  • - Oakland
  • - San Diego

Oklahoma

  • - Oklahoma City
  • - Oklahoma City

Arizona

  • - Tucson

Arkansas

  • - Little Rock

Colorado

  • - Aurora

Connecticut

  • - Hartford

Florida

  • - Tampa

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2011-02-24
Est. Completion 2020-04-21
Phase Phase 4

Sponsor

Daiichi Sankyo

236 total trials

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What the Registry Record Tells You About NCT01258075

The ClinicalTrials.gov registry entry for NCT01258075 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,746-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (91% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which High-dose colesevelam is the first listed.

NCT01258075 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Oklahoma, Arizona.

Frequently Asked Questions

What is clinical trial NCT01258075 about?

NCT01258075 is a clinical study titled "Colesevelam for Children With Type 2 Diabetes". This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have...

What is the current status of trial NCT01258075?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 236 participants. The study started on 2011-02-24. Estimated completion is 2020-04-21.

What conditions does trial NCT01258075 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT01258075?

The interventions under investigation include: High-dose colesevelam (DRUG), Low-dose colesevelam (DRUG).

Who is sponsoring clinical trial NCT01258075?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01258075 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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