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Type 2 Diabetes MellitusPhase 2BESTNCT00420511

Beta-Cell Function and Sitagliptin Trial (BEST)

A Phase 2 study testing Sitagliptin and metformin in people with Type 2 Diabetes Mellitus, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.

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

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sitagliptin and metformin
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 siteCanada
Study dates
Jan 2007to Sep 2009
Phase
Phase 2
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women between the ages of 30 and 75 inclusive
  • Physician-diagnosed type 2 diabetes on 0-2 oral hypoglycemic agents
  • Negative for anti-glutamic acid decarboxylase (anti-GAD_ antibodies (to rule out Latent Autoimmune Diabetes of Adults (LADA)
  • A1c at screening between 6.5% and 9% inclusive if on no oral hypoglycemic agents or 6.0% and 9.0% inclusive if on 1-2 oral hypoglycemic agents

Who cannot join

  • Current insulin therapy
  • Type 1 diabetes or secondary forms of diabetes
  • Any major illness with a life expectancy of < 5 years or that may interfere with the patient's participation in the study
  • Involvement in any other study requiring drug therapy
  • Renal dysfunction as evidenced by serum creatinine >/= 136 umol/L for males or >/= 124 umol/L for females or abnormal creatinine clearance (< 60 ml/min by Modification of Diet in Renal Disease (MDRD) formula)
  • Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases > 2.5 times the upper limit of normal
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  • Excessive alcohol consumption, defined as > 14 alcoholic drinks per week for males and > 9 alcoholic drinks per week for females
  • Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study. Reliable contraception includes: birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide. Any women who miss a menstrual period or think that they may be pregnant must have a pregnancy test as soon as possible
  • History of serious arrhythmia or atrioventricular block on baseline electrocardiogram
  • Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
  • Unwillingness to undergo multiple daily insulin injection therapy for 4 weeks
  • Unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Leadership Sinai Centre for Diabetes

    Toronto, Ontario, M5T 3L9

Other trials in Canada

About this study

Official title: A Randomized Controlled Pilot Study Assessing the Effect of Sitagliptin on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-blind, randomized controlled pilot study comparing the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate an important beta-cell protective capacity of sitagliptin.

Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor sitagliptin will preserve pancreatic beta-cell function.

Read the detailed description

Medications currently used in the treatment of T2DM have not been shown to modify the progressive decline in beta-cell function that occurs over time. Recent evidence, however, suggests that a new class of anti-diabetic medications, called dipeptidyl peptidase-IV (DPP-IV) inhibitors, may be able to protect beta cells and hence alter the natural history of T2DM. We thus wish to study the effect of sitagliptin (a DPP-IV inhibitor) on the preservation of beta-cell function in patients with T2DM randomized to either (i) sitagliptin and metformin or (ii) placebo and metformin.

Being tested
Sitagliptin, Placebo, metformin
Keywords
Type 2 diabetes, beta-cell function, sitagliptin, intensive insulin therapy
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.

  • SitagliptinDrug

    Also called januvia

    sitagliptin 100 mg once a day

  • PlaceboDrug

    placebo once a day

  • metforminDrug

    Also called glucophage

    metformin 1000 mg twice a day (bid) by mouth (po)

Study groups in NCT00420511
Study groupRoleWhat they receive
SitagliptinExperimentalSitagliptin 100mg once a day (od) by mouth (po)
Receives: Drug: Sitagliptin; Drug: metformin
Placebo armPlacebo comparatorPlacebo once a day (od) by mouth (po)
Receives: Drug: Placebo; Drug: metformin

What is being measured

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

  1. Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR

    Area-under-the-C-peptide-curve (AUCCpep) and area-under-the-glucose-curve (AUCgluc) from 0 to 240 minutes during meal tests were calculated using the trapezoidal rule. Insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Beta-cell function was assessed using the ratio of total AUCCpep to AUCgluc divided by HOMA-IR (AUCCpep/gluc/HOMA-IR), a measure of insulin secretion in the context of ambient insulin sensitivity, analogous to the disposition index and adaptation index. Higher AUCCpep/gluc/HOMA-IR is indicative of better beta-cell function.

    Measured: 48 weeks

Secondary outcomes (5)

  1. Insulinogenic Index Divided by HOMA-IR at 48 Weeks

    Insulinogenic index was calculated as the incremental change in insulin from 0 to 30 minutes divided by the incremental change in glucose over the same period of time. Insulinogenic index divided by HOMA-IR provides an additional measure of beta-cell function. A higher value indicates better beta-cell function

    Measured: 48 weeks

  2. Fasting Blood Glucose at 48 Weeks

    Measured: 48 weeks

  3. Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year

    Measured: 1 year

  4. Time to Loss of Glycemic Control

    Measured: 1 year

  5. Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy

    Measured: 1 year

Timeline

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

  1. First posted11 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00420511
Sponsor's protocol ID
065-00
Acronym
BEST
Status last verified
Dec 2011
First submitted
10 Jan 2007
Last updated
2 Jan 2012
Data monitoring committee
No

Publications

  • Stein CM, Kramer CK, Zinman B, Choi H, Opsteen C, Retnakaran R. Clinical predictors and time course of the improvement in beta-cell function with short-term intensive insulin therapy in patients with Type 2 diabetes. Diabet Med. 2015 May;32(5):645-52. doi: 10.1111/dme.12671. Epub 2015 Jan 7.

    PubMed 25495067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitagliptin and metformin in people with Type 2 Diabetes Mellitus, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.

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 4 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 2 Jan 2012. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 29 Dec 2011). 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?

Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR (time frame: 48 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 NCT00420511, 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 2 Jan 2012; AzTrials last refreshed its copy on 30 Oct 2026.

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