Diabetes Mellitus Type 2Phase 2NCT02097277

A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes

A Phase 2 study testing BMS-986036 in people with Diabetes Mellitus Type 2, run by Bristol-Myers Squibb at 16 sites in 2 countries.

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 assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: BMS-986036
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 219 participants
Where: 16 sitesin 2 countries
Study dates: 15 Apr 2014to 17 May 2016
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
Body mass index 30.0 to 50.0

Who cannot join

Any significant acute or chronic medical illness
Inability to self-administer subcutaneous injections
Inability to be venipunctured
Evidence of organ dysfunction beyond what is consistent with the target population
History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21) related compounds

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States10 sites

Anaheim Clinical Trials Llc
Anaheim, California, 92801
Metrolina Internal Medicine
Charlotte, North Carolina, 28204
Sterling Research Grp, Ltd.
Cincinnati, Ohio, 45219
All Medical Research, Llc
Cooper City, Florida, 33024
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Arkansas Clinical Research
Little Rock, Arkansas, 72205
National Research Institute
Los Angeles, California, 90057
Encompass Clinical Research
Spring Valley, California, 91978-1522
Encompass Clinical Research
Spring Valley, California, 91978
Premier Research
Trenton, New Jersey, 08611

Other trials in United States

Canada6 sites

Aggarwal And Associates
Brampton, Ontario, L6T 0G1
Rhodin Recherche Clinique
Drummondville, Quebec, J2B 7T1
Recherche Gcp Research
Montreal, Quebec, H1M 1B1
Alpha-Recherche Clinique
Québec, Quebec, G3K 2P8
Manna Research Vancouver
Vancouver, British Columbia, V6J 1S3
Medexa Recherche
Victoriaville, Quebec, G6P 6P6

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Obese Adults With Type-2 Diabetes

The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.

Conditions: Diabetes Mellitus Type 2
Being tested: BMS-986036, Placebo (Matching with BMS-986036)
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.

BMS-986036Biological
Placebo (Matching with BMS-986036)Biological

Study groups in NCT02097277
Study group	Role	What they receive
Treatment A: Placebo (Matching with BMS-986036 - Daily)	Placebo comparator	Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks Receives: Biological: Placebo (Matching with BMS-986036)
Arm 2: Treatment B: BMS-986036 (1 mg Daily)	Experimental	BMS-986036 1 mg subcutaneous injection once daily for 12 weeks Receives: Biological: BMS-986036
Treatment C: BMS-986036 (5 mg Daily)	Experimental	BMS-986036 5 mg subcutaneous injection once daily for 12 weeks Receives: Biological: BMS-986036
Treatment D: BMS-986036 (20 mg Daily)	Experimental	BMS-986036 20 mg subcutaneous injection once daily for 12 weeks Receives: Biological: BMS-986036
Treatment E: BMS-986036 (20 mg Weekly)	Experimental	BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks Receives: Biological: BMS-986036; Biological: Placebo (Matching with BMS-986036)

What is being measured

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

Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.
Measured: Baseline (Day 1) and Week 12

Secondary outcomes (16)

Change in Body Weight From Baseline to Week 12
Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.
Measured: Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)
Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*3+PG120*2)/8*(FPI+PI30*2+PI60*3+PI120*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load.
Measured: Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405.
Measured: Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)
The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)).
Measured: Baseline (Day 1) and Week 12
Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12
Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC).
Measured: Baseline (Day 1) and Week 12
Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12
Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC).
Measured: Bseline (Day 1) and Week 12
Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12
Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC).
Measured: Baseline (Day 1) and Week 12
Average Concentration (Cavg) of C-terminal Intact BMS-986036
Cavg of C-terminal Intact BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036
Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036
AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036
AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Average Concentration (Cavg) of Total BMS-986036
Cavg of Total BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Maximum Observed Concentration (Cmax) of Total BMS-986036
Maximum observed concentration (Cmax) of Total BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036
AUC [0-24 hours, ss] of Total BMS-986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036
AUC [0-168 hours, ss] of Total BMS- 986036 was reported.
Measured: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Percentage of Participants With ANTI-BMS-986036 Antibody Response
Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay.
Measured: Baseline and Day 126

Timeline

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

15 Apr 201417 May 2016

First posted27 Mar 2014 (estimated)
Study start15 Apr 2014
Primary completion22 Sep 2015
Study completion17 May 2016

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 (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02097277
Sponsor's protocol ID: MB130-002
Status last verified: Jul 2019
First submitted: 19 Mar 2014
Last updated: 31 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Charles ED, Neuschwander-Tetri BA, Pablo Frias J, Kundu S, Luo Y, Tirucherai GS, Christian R. Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study. Obesity (Silver Spring). 2019 Jan;27(1):41-49. doi: 10.1002/oby.22344. Epub 2018 Dec 6.
PubMed 30520566

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 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Obese Adults With Type-2 Diabetes
ClinicalTrials.gov ID: NCT02097277
Acronym / sponsor ID: MB130-002
Conditions: Diabetes Mellitus Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 219 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 15 Apr 2014 (actual)
Primary completion: 22 Sep 2015 (actual)
Study completion: 17 May 2016 (actual)
First posted: 27 Mar 2014 (estimated)
Results: Posted 9 May 2019

Clinical summary

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

The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Treatment A: Placebo (Matching with BMS-986036 - Daily)	Placebo comparator	Biological: Placebo (Matching with BMS-986036)Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks
Arm 2: Treatment B: BMS-986036 (1 mg Daily)	Experimental	Biological: BMS-986036BMS-986036 1 mg subcutaneous injection once daily for 12 weeks
Treatment C: BMS-986036 (5 mg Daily)	Experimental	Biological: BMS-986036BMS-986036 5 mg subcutaneous injection once daily for 12 weeks
Treatment D: BMS-986036 (20 mg Daily)	Experimental	Biological: BMS-986036BMS-986036 20 mg subcutaneous injection once daily for 12 weeks
Treatment E: BMS-986036 (20 mg Weekly)	Experimental	Biological: BMS-986036, Biological: Placebo (Matching with BMS-986036)BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
Body mass index 30.0 to 50.0

Key exclusion criteria (5 listed)

Any significant acute or chronic medical illness
Inability to self-administer subcutaneous injections
Inability to be venipunctured
Evidence of organ dysfunction beyond what is consistent with the target population
History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21) related compounds

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
BMS-986036	Biological	Arm 2: Treatment B: BMS-986036 (1 mg Daily), Treatment C: BMS-986036 (5 mg Daily), Treatment D: BMS-986036 (20 mg Daily), Treatment E: BMS-986036 (20 mg Weekly)
Placebo (Matching with BMS-986036)	Biological	Treatment A: Placebo (Matching with BMS-986036 - Daily), Treatment E: BMS-986036 (20 mg Weekly)

Primary outcome

Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.

16 secondary outcomes

Change in Body Weight From Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)
Time frame: Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: Baseline (Day 1) and Week 12
Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12
Time frame: Bseline (Day 1) and Week 12
Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
Average Concentration (Cavg) of C-terminal Intact BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Average Concentration (Cavg) of Total BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Maximum Observed Concentration (Cmax) of Total BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036
Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Percentage of Participants With ANTI-BMS-986036 Antibody Response
Time frame: Baseline and Day 126

Results and safety

Results posted to the registry on 9 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A: Placebo	24	22
Treatment B: BMS-986036 (1 mg Daily)	24	21
Treatment C: BMS-986036 (5 mg Daily)	24	22
Treatment D: BMS-986036 (20 mg Daily)	24	20
Treatment E: BMS-986036 (20 mg Weekly)	24	23

Primary outcome: Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12

Time frame: Baseline (Day 1) and Week 12. Mean (Standard Deviation). Unit: Percent Change

Measure	Treatment A: Placebo n = 24	Treatment B: BMS-986036 (1 mg Daily) n = 24	Treatment C: BMS-986036 (5 mg Daily) n = 24	Treatment D: BMS-986036 (20 mg Daily) n = 24	Treatment E: BMS-986036 (20 mg Weekly) n = 24
Value	0.0005 (0.00622)	0.0029 (0.00882)	0.0007 (0.00692)	0.0004 (0.00814)	-0.0004 (0.00418)

Population analysed: The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Placebo	1 of 24 (4.2%)	9 of 24 (37.5%)	0 of 24
Treatment B: BMS-986036 (1 mg Daily)	0 of 24 (0%)	12 of 24 (50%)	0 of 24
Treatment C: BMS-986036 (5 mg Daily)	0 of 24 (0%)	7 of 24 (29.2%)	0 of 24
Treatment D: BMS-986036 (20 mg Daily)	1 of 24 (4.2%)	10 of 24 (41.7%)	0 of 24
Treatment E: BMS-986036 (20 mg Weekly)	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30520566Charles ED, Neuschwander-Tetri BA, Pablo Frias J, Kundu S, Luo Y, Tirucherai GS, Christian R. Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study. Obesity (Silver Spring). 2019 Jan;27(1):41-49. doi: 10.1002/oby.22344. Epub 2018 Dec 6.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986036 in people with Diabetes Mellitus Type 2, run by Bristol-Myers Squibb at 16 sites in 2 countries.

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 2 inclusion and 5 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, 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 9 May 2019). 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 Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 (time frame: Baseline (Day 1) and Week 12). 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 NCT02097277, 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 31 Jul 2019.