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Type 2 Diabetes MellitusPhase 4WELKid DMNCT01258075

Colesevelam for Children With Type 2 Diabetes

A Phase 4 study testing High-dose colesevelam and Low-dose colesevelam in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 24 sites 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

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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
High-dose colesevelam and Low-dose colesevelam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
24 sitesUnited States
Study dates
24 Feb 2011to 21 Apr 2020
Phase
Phase 4
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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;
  • Written informed consent of study participation
  • Males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday);
  • HbA1c at screening between 7.0% and 10.0%, inclusive;
  • Fasting C-peptide >0.6 ng/mL; and
  • Anti-diabetic treatment at screening:
  • Treatment-naïve or untreated; OR
  • On metformin monotherapy: Metformin monotherapy has been initiated prior to screening.

Who cannot join

  • Fasting plasma glucose >270 mg/dL;
  • Diagnosis of type 1 diabetes;
  • History of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus;
  • Clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and Hb variants, that are not within the protocol-defined parameters
  • Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg
  • Use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids
Show all 12Show fewer
  • Genetic syndrome or disorder known to affect glucose
  • Participation in a weight loss program or another interventional research study within 60 days;
  • Female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening;
  • Female participants who are sexually active and unwilling to use appropriate contraception for the duration of the study;
  • History of bowel obstruction;
  • Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the Investigator, would prevent full participation

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45229

  • Study site

    Dallas, Texas, 75235

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Hartford, Connecticut, 06106

  • Study site

    Houston, Texas, 77030

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Little Rock, Arkansas, 72202

  • Study site

    Los Angeles, California, 90027

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New York, New York, 10032

  • Study site

    Oakland, California, 94609

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Raleigh, North Carolina, 27610

  • Study site

    San Antonio, Texas, 78207

  • Study site

    San Diego, California, 92123

  • Study site

    Springfield, Massachusetts, 01199

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

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.

Read the detailed description

Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months.

Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C [HbA1c]).

Being tested
High-dose colesevelam, Low-dose colesevelam
Keywords
Type 2 diabetes mellitus, Blood glucose, Anti-diabetic, Bile acid sequestrant, Colesevelam HCl, Oral suspension, Pediatric, Add-on therapy, Add-on to metformin, Metformin, Adolescent, Lipid
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.

  • High-dose colesevelamDrug

    Also called Welchol oral suspension

    3.75 grams colesevelam hydrochloride in oral suspension

  • Low-dose colesevelamDrug

    Also called Welchol oral suspension

    0.625 grams colesevelam hydrochloride in oral suspension

Study groups in NCT01258075
Study groupRoleWhat they receive
ColesevelamExperimentalHigh-dose colesevelam suspended in a drink for oral administration once daily with dinner
Receives: Drug: High-dose colesevelam
Placebo proxyExperimentalLow-dose colesevelam suspended in a drink for oral administration once daily with dinner
Receives: Drug: Low-dose colesevelam

What is being measured

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

  1. Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6

    The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

    Measured: Baseline to Month 6 post-dose

Secondary outcomes (6)

  1. Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12

    The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

    Measured: Baseline to Month 12 post-dose

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12

    Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.

    Measured: Baseline to Month 12 post-dose

  3. Number of Participants Achieving a Response to Therapy to Month 12

    Participants achieving a response to therapy, ie, glycemic control, were assessed with the last observation after 1 month before any rescue therapy carried forward at Month 6 and Month 12. Response to therapy was defined as HbA1c <7.0% or <6.5%, reduction in HbA1c ≥0.7% or ≥0.5% from baseline, and/or reduction in FPG ≥30 mg/dL from baseline.

    Measured: Baseline to Month 12 post-dose

  4. Percent Change From Baseline to Month 6 in Plasma Lipids

    The percent change in plasma lipids from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

    Measured: Baseline to Month 6 post-dose

  5. Percent Change From Baseline to Month 6 in Triglycerides

    The percent change in triglycerides from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

    Measured: Baseline to Month 6 post-dose

  6. Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria

    Rescue criteria was defined as HbA1c levels ≥8.5% after 3 months or ≥7.5% after 6 months (≥173 days) (confirmed persistent hyperglycemia) of study medication treatment, as measured by the central laboratory.

    Measured: Baseline to Month 12 post-dose

Timeline

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

  1. First posted10 Dec 2010 (estimated)
  2. Study start24 Feb 2011
  3. Primary completion1 Nov 2019
  4. Study completion21 Apr 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01258075
Sponsor's protocol ID
WEL-A-U307
Acronym
WELKid DM
Status last verified
Apr 2021
First submitted
9 Dec 2010
Last updated
13 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High-dose colesevelam and Low-dose colesevelam in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 24 sites 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 22 Dec 2020). 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?

Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 (time frame: Baseline to Month 6 post-dose). 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 NCT01258075.

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 13 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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