Type 2 Diabetes MellitusPhase 2NCT00361153
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing Colesevelam hydrochloride in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Colesevelam hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the trial:
- Have given written informed consent
- Ages 18 to 75 years, inclusive
- Diagnosis of type 2 diabetes mellitus of at least 3 months duration
- HbA1C 7.0- 10.0%, inclusive
- Antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization
- Women may be enrolled if they are not pregnant (negative serum βHCG at the Screening Visit), are not breast-feeding, and do not plan to become pregnant during the trial. In addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. An acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. Abstinence, partner's use of condoms, and partner's vasectomy are NOT acceptable methods of contraception
- BMI 25 - 45 kg/M sq, inclusive
Who cannot join
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
- Treatment with WelChol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
- Treatment with thiazolidinediones
- History of dysphagia, swallowing disorders, or intestinal motility disorder
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- Serum triglyceride >500 mg/dL at Visit 1
- Serum LDL-C <60 mg/dL at Visit 1
- Any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
- Use of any investigational drug within 30 days before randomization
- Chronic treatment with oral corticosteroids
- History of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Research Associates
San Antonio, Texas, 78229
About this study
This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.
Read the detailed description
Single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in subjects with type 2 diabetes mellitus. Two parallel treatment groups include double-blind colesevelam or placebo. A screening period may be up to 18 weeks to withdraw non sulfonylurea antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. To evaluate hepatic and peripheral insulin sensitivity, subjects will undergo a two-step hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and after 8 weeks of treatment. To evaluate oral glucose absorption, subjects will undergo two oral glucose tolerance tests (OGTT) at pre randomization, one without colesevelam and one with colesevelam, and one OGTT at the end of the treatment period..
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Colesevelam hydrochloride, 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 hydrochlorideDrug
Also called Welchol
Welchol tablet 625mg
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Colesevelam hydrochloride Receives: Drug: Colesevelam hydrochloride |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value.
Measured: 8 weeks
Secondary outcomes (3)
To evaluate the effect of 2 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method.
Measured: 2 weeks
To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement.
Measured: 8 weeks
To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Director Clinical Development, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361153
- Sponsor's protocol ID
- WEL-202
- Status last verified
- Jun 2008
- First submitted
- 3 Aug 2006
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwartz SL, Lai YL, Xu J, Abby SL, Misir S, Jones MR, Nagendran S. The effect of colesevelam hydrochloride on insulin sensitivity and secretion in patients with type 2 diabetes: a pilot study. Metab Syndr Relat Disord. 2010 Apr;8(2):179-88. doi: 10.1089/met.2009.0049.
PubMed 20059361
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00361153
- Acronym / sponsor ID
- WEL-202
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.
Detailed description
Single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in subjects with type 2 diabetes mellitus. Two parallel treatment groups include double-blind colesevelam or placebo. A screening period may be up to 18 weeks to withdraw non sulfonylurea antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. To evaluate hepatic and peripheral insulin sensitivity, subjects will undergo a two-step hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and after 8 weeks of treatment. To evaluate oral glucose absorption, subjects will undergo two oral glucose tolerance tests (OGTT) at pre randomization, one without colesevelam and one with colesevelam, and one OGTT at the end of the treatment period..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Colesevelam hydrochlorideColesevelam hydrochloride |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the trial:
- Have given written informed consent
- Ages 18 to 75 years, inclusive
- Diagnosis of type 2 diabetes mellitus of at least 3 months duration
- HbA1C 7.0- 10.0%, inclusive
Key exclusion criteria (12 listed)
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
- Treatment with WelChol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
- Treatment with thiazolidinediones
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 hydrochlorideAlso: WelcholWelchol tablet 625mg | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value.
Time frame: 8 weeks
3 secondary outcomes
To evaluate the effect of 2 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method.
Time frame: 2 weeks
To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement.
Time frame: 8 weeks
To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
- Derived from this study: PubMed 20059361Schwartz SL, Lai YL, Xu J, Abby SL, Misir S, Jones MR, Nagendran S. The effect of colesevelam hydrochloride on insulin sensitivity and secretion in patients with type 2 diabetes: a pilot study. Metab Syndr Relat Disord. 2010 Apr;8(2):179-88. doi: 10.1089/met.2009.0049.
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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.
Director Clinical Development study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colesevelam hydrochloride in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo 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 8 inclusion and 12 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 25 Jun 2008. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value. (time frame: 8 weeks). 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 NCT00361153, which also lists 1 linked publication.
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 25 Jun 2008.