Type 2 DiabetesPhase 2/3NCT00993824

Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

A Phase 2/3 study testing colesevelam HCl in people with Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: colesevelam HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Sep 2011
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

International Diabetes Center
Minneapolis, Minnesota, 55416

Other trials in United States

About this study

Official title: Use of Continuous Glucose Monitoring With Ambulatory Glucose Profile Analysis to Demonstrate the Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

Read the detailed description

To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: colesevelam HCl, placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

colesevelam HClDrug
Also called Welchol
3.75 grams of colesevelam HCl (6 tablets)
placeboDrug

Study groups in NCT00993824
Study group	Role	What they receive
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. Receives: Drug: colesevelam HCl; Drug: 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. Receives: Drug: colesevelam HCl; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Sep 2011

First posted14 Oct 2009 (estimated)
Study startSep 2009
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00993824
Sponsor's protocol ID: 03901-09-C
Status last verified: Feb 2014
First submitted: 12 Oct 2009
Last updated: 30 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 18852398
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.
PubMed 18473688
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.
PubMed 18663165
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.
PubMed 19132850
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.
PubMed 17379048

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Continuous Glucose Monitoring With Ambulatory Glucose Profile Analysis to Demonstrate the Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00993824
Acronym / sponsor ID: 03901-09-C
Conditions: Type 2 Diabetes
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: International Diabetes Center at Park Nicollet, Daiichi Sankyo
Study start: Sep 2009
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 14 Oct 2009 (estimated)
Results: Posted 17 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Welchol then Placebo	Placebo comparator	Drug: colesevelam HCl, Drug: placebo3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.
Placebo then Welchol	Placebo comparator	Drug: colesevelam HCl, Drug: placeboPlacebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
colesevelam HClAlso: Welchol3.75 grams of colesevelam HCl (6 tablets)	Drug	Placebo then Welchol, Welchol then Placebo
placebo	Drug	Placebo then Welchol, Welchol then Placebo

Primary outcome

Total Norm AUC Average by Group (Normalized)
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
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.
Sleep Norm AUC Average by Group (Normalized)
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Overnight glucose captured by CGM.
Wake Norm AUC Average by Group (Normalized)
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Wake glucose captured by continuous glucose monitoring (CGM).
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Welchol Then Placebo	11	11
Placebo Then Welchol	10	10

Primary outcome: Total Norm AUC Average by Group (Normalized)

Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.. Mean (Standard Deviation). Unit: mg/(dL/hr) normalized

Measure	Welchol Then Placebo n = 11	Placebo Then Welchol n = 10
Start of Treatment 1	150.8 (10.8)	175.9 (29.2)
End of Treatment 1	149.9 (17.2)	175.1 (27.4)
Start of Treatment 2	163.2 (23.5)	159.4 (23.9)
End of Treatment 2	177.9 (33.2)	159.4 (25.3)

Primary outcome: Sleep Norm AUC Average by Group (Normalized)

Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.. Mean (Standard Deviation). Unit: mg/(dL/hr) normalized

Measure	Welchol Then Placebo n = 11	Placebo Then Welchol n = 10
Start of Treatment 1	147.4 (16.6)	161.9 (25.7)
End of Treatment 1	148.0 (24.0)	160.2 (27.9)
Start of Treatment 2	158.8 (31.8)	147.9 (24.4)
End of Treatment 2	172.0 (32.5)	143.6 (18.6)

Primary outcome: Wake Norm AUC Average by Group (Normalized)

Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.. Mean (Standard Deviation). Unit: mg/(dL/hr) (normalized)

Measure	Welchol Then Placebo n = 11	Placebo Then Welchol n = 10
Start of Treatment 1	153.3 (11.7)	180.9 (32.2)
End of Treatment 1	151.2 (16.0)	180.6 (29.6)
Start of Treatment 2	165.2 (21.2)	163.8 (25.6)
End of Treatment 2	180.9 (34.2)	165.2 (30.5)

Primary outcome: Hypoglycemia Percentage of Time <70 mg/dL Average by Group

Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.. Mean (Standard Deviation). Unit: percentage of time <70 mg/dL

Measure	Welchol Then Placebo n = 11	Placebo Then Welchol n = 10
Start of Treatment 1	1.2 (1.3)	0.3 (0.6)
End of Treatment 1	0.8 (1.1)	0.4 (0.6)
Start of Treatment 2	0.8 (1.2)	0.7 (1.0)
End of Treatment 2	0.6 (1.2)	0.6 (1.1)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Welchol	0 of 21 (0%)	0 of 21 (0%)	Not reported
Placebo	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18852398Bays 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.
Results publication: PubMed 18473688Mazze 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.
Results publication: PubMed 18663165Goldberg 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.
Results publication: PubMed 19132850Mazze 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.
Results publication: PubMed 17379048Zieve 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roger S. Mazze, PhD study director

International Diabetes Center at Park Nicollet

Elinor S. Strock, APRN, BC principal investigator

International Diabetes Center at Park Nicollet

Robert M. Cuddihy, MD principal investigator

International Diabetes Center at Park Nicollet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing colesevelam HCl in people with Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Norm AUC Average by Group (Normalized) (time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00993824, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.