NCT00993824

Brief Summary

The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Sep 2009

Typical duration for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 17, 2014

Completed
Last Updated

November 30, 2015

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

October 12, 2009

Results QC Date

September 5, 2013

Last Update Submit

November 25, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

  • Total Norm AUC Average by Group (Normalized)

    Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

    2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

  • Sleep Norm AUC Average by Group (Normalized)

    Overnight glucose captured by CGM.

    2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

  • Wake Norm AUC Average by Group (Normalized)

    Wake glucose captured by continuous glucose monitoring (CGM).

    2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

  • Hypoglycemia Percentage of Time <70 mg/dL Average by Group

    Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM\<70 mg/dL)

    2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

Study Arms (2)

Welchol then Placebo

PLACEBO COMPARATOR

3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.

Drug: colesevelam HClDrug: placebo

Placebo then Welchol

PLACEBO COMPARATOR

Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.

Drug: colesevelam HClDrug: placebo

Interventions

colesevelam HClDRUG

3.75 grams of colesevelam HCl (6 tablets)

Also known as: Welchol
Placebo then WelcholWelchol then Placebo
placeboDRUG
Placebo then WelcholWelchol then Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects ≥18 and ≤75 years of age
  • Clinical diagnosis of type 2 diabetes
  • Currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
  • HbA1c of 7.0-9.0% inclusive
  • If taking lipid lowering medications, stable dose for \>30 days

You may not qualify if:

  • Taken oral or injected prednisone or cortisone medications in the previous 30 days. (Topical or inhaled steroids will not be considered excluded medications.)
  • Current use of insulin or TZD's, or incretins
  • LDL \<70 mg/dL
  • Serum triglycerides \>500 mg/dL
  • History of hypertriglyceridemia-induced pancreatitis
  • History of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
  • History or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
  • Unable to follow the study protocol
  • Unable to speak, read and write in English
  • Pregnant, planning to become pregnant, breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (5)

  • Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.

    PMID: 18852398RESULT

  • Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.

    PMID: 18473688RESULT

  • Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.

    PMID: 18663165RESULT

  • Mazze RS, Strock E, Borgman S, Wesley D, Stout P, Racchini J. Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time? Diabetes Technol Ther. 2009 Jan;11(1):11-8. doi: 10.1089/dia.2008.0041.

    PMID: 19132850RESULT

  • Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.

    PMID: 17379048RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbons

Results Point of Contact

Title
Roger Mazze PhD
Organization
International Diabetes Center
rmazze@aol.com
952-993-3796

Study Officials

  • Roger S. Mazze, PhD

    International Diabetes Center at Park Nicollet

    STUDY DIRECTOR

  • Elinor S. Strock, APRN, BC

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

  • Robert M. Cuddihy, MD

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2009

First Posted

October 14, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 30, 2015

Results First Posted

June 17, 2014

Record last verified: 2014-02

Locations

US(1)