Type 2 Diabetes MellitusPhase 1/2NCT01804842

Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM

A Phase 1/2 study testing Met DR in people with Type 2 Diabetes Mellitus, run by Elcelyx Therapeutics, Inc..

Completed

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

Trial summary

This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered once daily in the morning (qAM), administered once daily in the evening (qPM), and administered twice daily (BID) on circulating glucose concentrations and metformin pharmacokinetics (PK) in subjects with type 2 diabetes… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Met DR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: No sites listed yet
Study dates: Dec 2012to Apr 2013
Phase: Phase 1/2
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 to 70 (inclusive) years old at Visit 1 (Screening)
Was diagnosed with type 2 diabetes mellitus with
HbA1c between 6.0 to 9.5% (inclusive) for subjects managing their diabetes with:
Diet and exercise alone, or ii. A stable regimen (minimum of 2 months at Visit 1) of metformin alone, or iii. A stable regimen (minimum of 2 months at Visit 1) of DPP-4 inhibitor alone OR
HbA1c between 6.0 to 8.5% (inclusive) for subjects managing their diabetes with a stable (minimum of 2 months at Visit 1) combination regimen of metformin and DPP-4 inhibitors
Had normal renal function with an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation

Show all 14Show fewer

Body mass index (BMI) of 25.0 to 40.0 kg/m^2 (inclusive) at Screening
Male, or if female and met all of the following criteria:
Not breastfeeding
Negative pregnancy test result (human chorionic gonadotropin, beta subunit) at Visit 1 (Screening) (not applicable to hysterectomized females)
Surgically sterile, postmenopausal, or if of childbearing potential, practiced and was willing to continue to practice appropriate birth control during the entire duration of the study
Had a physical examination with no clinically significant abnormalities as judged by the investigator
Ability to understand and willingness to adhere to protocol requirements
If on chronic thyroid pharmacologic therapy, the dose must have been stable for at least 3 months prior to Visit 1 (Screening), and must have thyroid-stimulating hormone (TSH) test result in normal range at Visit 1 (Screening)

Who cannot join

Had a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
Hepatic disease
Renal disease
Gastrointestinal disease
Endocrine disorder except diabetes
Cardiovascular disease

Show all 28Show fewer

Central nervous system diseases
Psychiatric or neurological disorders
Organ transplantation
Chronic or acute infection
Orthostatic hypotension, fainting spells or blackouts
Allergy or hypersensitivity
Had any chronic disease requiring medication that was adjusted in the past 90 days (subjects could take acute intermittent over-the-counter medications such as Tylenol, if needed)
Had any drug treatment that affects gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid within 2 days of Visit 1 (Screening)
Had major surgery of any kind within 6 months of Visit 1 (Screening)
Had received a blood transfusion within 6 months of Visit 1 (Screening)
Had a history of >5 kg weight change within 3 months of Visit 1 (Screening)
Had clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities other than those expected in subjects with type 2 diabetes and judged by the investigator to be clinically significant at Visit 1 (Screening)
Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
Abused drugs or alcohol or had a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures
Had donated blood within 3 months of the date of the first dose of randomized study medication, or was planning to donate blood during the study
Used insulin within 3 months of Visit 1 (Screening)
Had received GLP-1 receptor agonists and/or thiazolidinedione treatment within 6 months of Visit 1 (Screening)
Had known intolerance to metformin
Had received any investigational drug within 2 months (or five half-lives of the investigational drug, whichever was greater) of Visit 1 (Screening)
Had known allergies or hypersensitivity to any component of study treatment
Was employed by Elcelyx Therapeutics, Inc. (that is an employee, temporary contract worker, or designee of the company)
Smoked more than 10 cigarettes per day, 3 cigars per day, 3 pipes per day, used more than 1 can of smokeless tobacco per week, or used a combination of tobacco products that approximate nicotine doses equivalent to 10 cigarettes per day

About this study

Official title: A Randomized, Crossover Study Assessing the Effect of EFB0027 on Plasma Glucose and Pharmacokinetics in Subjects With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Met DR
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.

Met DRDrug
Also called EFB0027
metformin delayed-release tablets

Study groups in NCT01804842
Study group	Role	What they receive
500 mg Met DR BID	Active comparator	Two doses of 500 mg metformin delayed-release Receives: Drug: Met DR
1000 mg Met DR qAM	Experimental	One dose of 1000 mg metformin delayed-release in the morning Receives: Drug: Met DR
1000 mg Met DR qPM	Experimental	One dose of 1000 mg metformin delayed-release in the evening Receives: Drug: Met DR

What is being measured

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

AUC (0-24) of Plasma Metformin
AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Measured: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
Cmax of Plasma Metformin
Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Measured: Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
AUC (0-24) of Plasma Glucose
AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Measured: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.
Rmax (0-24) of Plasma Glucose
Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Measured: Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.

Timeline

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

Dec 2012Apr 2013

First posted5 Mar 2013 (estimated)
Study startDec 2012
Primary completionApr 2013
Study completionApr 2013

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 (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01804842
Sponsor's protocol ID: LCRM104
Status last verified: Oct 2016
First submitted: 4 Mar 2013
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.
PubMed 26285584
DeFronzo RA, Buse JB, Kim T, Burns C, Skare S, Baron A, Fineman M. Once-daily delayed-release metformin lowers plasma glucose and enhances fasting and postprandial GLP-1 and PYY: results from two randomised trials. Diabetologia. 2016 Aug;59(8):1645-54. doi: 10.1007/s00125-016-3992-6. Epub 2016 May 23.
PubMed 27216492

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?

Official record

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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Crossover Study Assessing the Effect of EFB0027 on Plasma Glucose and Pharmacokinetics in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01804842
Acronym / sponsor ID: LCRM104
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Elcelyx Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 5 Mar 2013 (estimated)
Results: Posted 7 Apr 2016

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
500 mg Met DR BID	Active comparator	Drug: Met DRTwo doses of 500 mg metformin delayed-release
1000 mg Met DR qAM	Experimental	Drug: Met DROne dose of 1000 mg metformin delayed-release in the morning
1000 mg Met DR qPM	Experimental	Drug: Met DROne dose of 1000 mg metformin delayed-release in the evening

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

18 to 70 (inclusive) years old at Visit 1 (Screening)
Was diagnosed with type 2 diabetes mellitus with
Had normal renal function with an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation
Body mass index (BMI) of 25.0 to 40.0 kg/m^2 (inclusive) at Screening
Male, or if female and met all of the following criteria:

Key exclusion criteria (28 listed)

Had a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
Had any chronic disease requiring medication that was adjusted in the past 90 days (subjects could take acute intermittent over-the-counter medications such as Tylenol, if needed)
Had any drug treatment that affects gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid within 2 days of Visit 1 (Screening)
Had major surgery of any kind within 6 months of Visit 1 (Screening)
Had received a blood transfusion within 6 months of Visit 1 (Screening)

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
Met DRAlso: EFB0027metformin delayed-release tablets	Drug	1000 mg Met DR qAM, 1000 mg Met DR qPM, 500 mg Met DR BID

Primary outcome

AUC (0-24) of Plasma Metformin
Time frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Cmax of Plasma Metformin
Time frame: Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
AUC (0-24) of Plasma Glucose
Time frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.
AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Rmax (0-24) of Plasma Glucose
Time frame: Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.

Results and safety

Results posted to the registry on 7 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: ABC	9	6
Sequence 2: BCA	8	6
Sequence 3: CAB	9	8

Primary outcome: AUC (0-24) of Plasma Metformin

Time frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.. Least squares mean (Standard Error). Unit: ng*h/mL

Measure	500 mg Met DR BID n = 12	1000 mg Met DR qAM n = 12	1000 mg Met DR qPM n = 12
Value	7771 (619)	5559 (433)	7757 (604)

1000 mg Met DR qAM vs 1000 mg Met DR qPM: % Ratio of LS Means: 71.7 (90% CI 61.14 to 84.01), p = 0.0018, ANOVA
500 mg Met DR BID vs 1000 mg Met DR qAM: % Ratio of LS Means: 71.5 (90% CI 60.85 to 84.09), p = 0.0020, ANOVA
500 mg Met DR BID vs 1000 mg Met DR qPM: % Ratio of LS Means: 99.8 (90% CI 84.91 to 117.33), p = 0.9844, ANOVA

Population analysed: Evaluable Population

Primary outcome: Cmax of Plasma Metformin

Time frame: Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.. Least squares mean (Standard Error). Unit: ng/mL

Measure	500 mg Met DR BID n = 12	1000 mg Met DR qAM n = 12	1000 mg Met DR qPM n = 12
Value	780 (71.7)	868 (79.8)	1035 (95.2)

1000 mg Met DR qAM vs 1000 mg Met DR qPM: % Ratio of LS Means: 83.8 (90% CI 68.10 to 103.23), p = 0.1595, ANOVA
500 mg Met DR BID vs 1000 mg Met DR qAM: % Ratio of LS Means: 111.3 (90% CI 90.37 to 136.99), p = 0.3867, ANOVA
500 mg Met DR BID vs 1000 mg Met DR qPM: % Ratio of LS Means: 132.7 (90% CI 107.78 to 163.39), p = 0.0294, ANOVA

Population analysed: Evaluable Population

Primary outcome: AUC (0-24) of Plasma Glucose

Time frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.. Least squares mean (Standard Error). Unit: mg*h/dL

Measure	500 mg Met DR BID n = 12	1000 mg Met DR qAM n = 12	1000 mg Met DR qPM n = 12
Pre-Treatment	4668 (581)	4947 (615)	4961 (617)
On-Treatment	4438 (552)	4503 (560)	4509 (561)

1000 mg Met DR qAM: % Ratio of LS Means: 91.0 (95% CI 85.70 to 96.67), p = 0.0028, ANOVA
1000 mg Met DR qPM: % Ratio of LS Means: 90.9 (95% CI 85.58 to 96.53), p = 0.0024, ANOVA
500 mg Met DR BID: % Ratio of LS Means: 95.1 (95% CI 89.54 to 100.99), p = 0.0992, ANOVA

Population analysed: Evaluable Population

Primary outcome: Rmax (0-24) of Plasma Glucose

Time frame: Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.. Least squares mean (Standard Error). Unit: mg/dL

Measure	500 mg Met DR BID n = 12	1000 mg Met DR qAM n = 12	1000 mg Met DR qPM n = 12
Pre-Treatment	279 (29.9)	290 (31.1)	302 (32.4)
On-Treatment	263 (28.2)	262 (28.1)	273 (29.4)

1000 mg Met DR qAM: % Ratio of LS Means: 90.4 (95% CI 85.55 to 95.56), p = 0.0006, ANOVA
1000 mg Met DR qPM: % Ratio of LS Means: 90.5 (95% CI 85.65 to 95.67), p = 0.0007, ANOVA
500 mg Met DR BID: % Ratio of LS Means: 94.3 (95% CI 89.24 to 99.69), p = 0.0389, ANOVA

Population analysed: Evaluable Population

Adverse events

Time frame: Approximately 36 to 91 days depending on the number of days between the start of Visit 1 and Visit 2 and the number of washout days between the treatment periods.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1000 mg Met DR qAM	0 of 23 (0%)	6 of 23 (26.1%)	Not reported
1000 mg Met DR qPM	0 of 24 (0%)	5 of 24 (20.8%)	Not reported
500 mg Met DR BID	0 of 23 (0%)	7 of 23 (30.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26285584Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.
Background: PubMed 27216492DeFronzo RA, Buse JB, Kim T, Burns C, Skare S, Baron A, Fineman M. Once-daily delayed-release metformin lowers plasma glucose and enhances fasting and postprandial GLP-1 and PYY: results from two randomised trials. Diabetologia. 2016 Aug;59(8):1645-54. doi: 10.1007/s00125-016-3992-6. Epub 2016 May 23.

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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.

Danielle Armas, MD principal investigator

Celerion

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Met DR in people with Type 2 Diabetes Mellitus, run by Elcelyx Therapeutics, Inc..

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 14 inclusion and 28 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 Apr 2016). 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?

AUC (0-24) of Plasma Metformin (time frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.). 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 NCT01804842, which also lists 2 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 21 Oct 2016.