Type 2 Diabetes MellitusPhase 1NCT01614769

Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)

A Phase 1 study testing Glimepiride 2 mg, Glimepiride 4 mg and Hypoglycemic Clamp in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. The primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Glimepiride 2 mg, Glimepiride 4 mg and Hypoglycemic Clamp
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: No sites listed yet
Study dates: 18 Jul 2012to 23 Jan 2013
Phase: Phase 1
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Has clinically confirmed diagnosis of type 2 diabetes mellitus (T2DM) controlled by diet and exercise alone, or treated by metformin only with same dose for >= 12 weeks prior to screening visit.
Females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug.
Females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation.
Is in good health, other than T2DM.
Has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. If discontinued use for previous 3 months, may be enrolled at investigator's discretion.
Will follow American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to study until poststudy visit.

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At screening visit has a Body Mass Index (BMI) =< 40 kg/m^2.
At screening visit has a Hemoglobin A1c (HbA1c) of >= 7% and < 10% (+/- 0.1%).
On the morning of randomization at predose has fasting plasma glucose (FPG) >= 126 mg/dL, and =< 250 mg/dL.

Who cannot join

Has a history of stroke, chronic seizures, or major neurological disorder.
Has a history of any illness that might confound the results of the study or pose additional risk to the participant.
Has a history of type 1 diabetes mellitus, ketoacidosis, C-peptide =< 0.8 ng/mL, secondary forms of diabetes or diabetic complications.
Has a history of neoplastic disease.
Is a nursing mother.
Has been treated =< one year of screening visit with sulfonylurea agents, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs, or insulin.

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Has received treatment within =< 12 weeks of screening visit with a peroxisome proliferator-activated receptor γ (PPARγ) agonist.
Is taking medications for a co-morbid condition or anticipates taking new medications beginning 2 weeks prior to study.
Consumes excessive amounts of alcohol or caffeinated beverages.
Is a regular user of illicit drugs, or has a history of drug abuse within the previous 6 months.
Has had major surgery, lost 500 mL of blood, or participated in another investigational study within 4 weeks prior to screening visit.
Is on a weight loss program, but not in the maintenance phase, or treated with a weight loss medication within 8 weeks of prestudy visit.
Has a history of severe allergies, anaphylactic reaction or intolerability to drugs, food, insulin, glimepiride or sulfonamide derivatives.

About this study

Official title: A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Placebo, Glimepiride 2 mg, Glimepiride 4 mg, Hypoglycemic Clamp
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.

PlaceboDrug
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Glimepiride 2 mgDrug
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Glimepiride 4 mgDrug
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Hypoglycemic ClampProcedure or surgery
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.

Study groups in NCT01614769
Study group	Role	What they receive
Placebo → Glimepiride 2 mg → Glimepiride 4 mg	Experimental	Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period. Receives: Drug: Placebo; Drug: Glimepiride 2 mg; Drug: Glimepiride 4 mg; Procedure: Hypoglycemic Clamp
Glimepiride 2 mg → Glimepiride 4 mg → Placebo	Experimental	Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period. Receives: Drug: Placebo; Drug: Glimepiride 2 mg; Drug: Glimepiride 4 mg; Procedure: Hypoglycemic Clamp
Glimepiride 4 mg → Placebo → Glimepiride 2 mg	Experimental	Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period. Receives: Drug: Placebo; Drug: Glimepiride 2 mg; Drug: Glimepiride 4 mg; Procedure: Hypoglycemic Clamp
Placebo → Glimepiride 4 mg → Glimepiride 2 mg	Experimental	Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period. Receives: Drug: Placebo; Drug: Glimepiride 2 mg; Drug: Glimepiride 4 mg; Procedure: Hypoglycemic Clamp
Glimepiride 2 mg → Placebo → Glimepiride 4 mg	Experimental	Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period. Receives: Drug: Placebo; Drug: Glimepiride 2 mg; Drug: Glimepiride 4 mg; Procedure: Hypoglycemic Clamp
Glimepiride 4 mg → Glimepiride 2 mg → Placebo	Experimental	Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period. Receives: Drug: Placebo; Drug: Glimepiride 2 mg; Drug: Glimepiride 4 mg; Procedure: Hypoglycemic Clamp

What is being measured

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

Recovery Time From Hypoglycemia to Euglycemia
Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.
Measured: From 1 to 180 minutes post hypoglycemic clamp
Rate of Recovery From Hypoglycemia to Euglycemia
The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.
Measured: From 1 to 180 minutes post hypoglycemic clamp
Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery
The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.
Measured: From 1 to 180 minutes post hypoglycemic clamp

Timeline

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

18 Jul 201223 Jan 2013

First posted8 Jun 2012 (estimated)
Study start18 Jul 2012
Primary completion9 Jan 2013
Study completion23 Jan 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.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01614769
Sponsor's protocol ID: 0000-253
Status last verified: Jul 2018
First submitted: 6 Jun 2012
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01614769
Acronym / sponsor ID: 0000-253
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 18 Jul 2012 (actual)
Primary completion: 9 Jan 2013 (actual)
Study completion: 23 Jan 2013 (actual)
First posted: 8 Jun 2012 (estimated)
Results: Posted 24 Feb 2014

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo → Glimepiride 2 mg → Glimepiride 4 mg	Experimental	Drug: Placebo, Drug: Glimepiride 2 mg, Drug: Glimepiride 4 mg, Procedure: Hypoglycemic ClampParticipants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
Glimepiride 2 mg → Glimepiride 4 mg → Placebo	Experimental	Drug: Placebo, Drug: Glimepiride 2 mg, Drug: Glimepiride 4 mg, Procedure: Hypoglycemic ClampParticipants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
Glimepiride 4 mg → Placebo → Glimepiride 2 mg	Experimental	Drug: Placebo, Drug: Glimepiride 2 mg, Drug: Glimepiride 4 mg, Procedure: Hypoglycemic ClampParticipants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
Placebo → Glimepiride 4 mg → Glimepiride 2 mg	Experimental	Drug: Placebo, Drug: Glimepiride 2 mg, Drug: Glimepiride 4 mg, Procedure: Hypoglycemic ClampParticipants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
Glimepiride 2 mg → Placebo → Glimepiride 4 mg	Experimental	Drug: Placebo, Drug: Glimepiride 2 mg, Drug: Glimepiride 4 mg, Procedure: Hypoglycemic ClampParticipants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
Glimepiride 4 mg → Glimepiride 2 mg → Placebo	Experimental	Drug: Placebo, Drug: Glimepiride 2 mg, Drug: Glimepiride 4 mg, Procedure: Hypoglycemic ClampParticipants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Has clinically confirmed diagnosis of type 2 diabetes mellitus (T2DM) controlled by diet and exercise alone, or treated by metformin only with same dose for >= 12 weeks prior to screening visit.
Females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug.
Females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation.
Is in good health, other than T2DM.
Has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. If discontinued use for previous 3 months, may be enrolled at investigator's discretion.

Key exclusion criteria (13 listed)

Has a history of stroke, chronic seizures, or major neurological disorder.
Has a history of any illness that might confound the results of the study or pose additional risk to the participant.
Has a history of type 1 diabetes mellitus, ketoacidosis, C-peptide =< 0.8 ng/mL, secondary forms of diabetes or diabetic complications.
Has a history of neoplastic disease.
Is a nursing mother.

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
PlaceboTwo gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.	Drug	Glimepiride 2 mg → Glimepiride 4 mg → Placebo, Glimepiride 2 mg → Placebo → Glimepiride 4 mg, Glimepiride 4 mg → Glimepiride 2 mg → Placebo, Glimepiride 4 mg → Placebo → Glimepiride 2 mg, Placebo → Glimepiride 2 mg → Glimepiride 4 mg, Placebo → Glimepiride 4 mg → Glimepiride 2 mg
Glimepiride 2 mgOne placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.	Drug	Glimepiride 2 mg → Glimepiride 4 mg → Placebo, Glimepiride 2 mg → Placebo → Glimepiride 4 mg, Glimepiride 4 mg → Glimepiride 2 mg → Placebo, Glimepiride 4 mg → Placebo → Glimepiride 2 mg, Placebo → Glimepiride 2 mg → Glimepiride 4 mg, Placebo → Glimepiride 4 mg → Glimepiride 2 mg
Glimepiride 4 mgTwo 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.	Drug	Glimepiride 2 mg → Glimepiride 4 mg → Placebo, Glimepiride 2 mg → Placebo → Glimepiride 4 mg, Glimepiride 4 mg → Glimepiride 2 mg → Placebo, Glimepiride 4 mg → Placebo → Glimepiride 2 mg, Placebo → Glimepiride 2 mg → Glimepiride 4 mg, Placebo → Glimepiride 4 mg → Glimepiride 2 mg
Hypoglycemic ClampOn Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.	Procedure or surgery	Glimepiride 2 mg → Glimepiride 4 mg → Placebo, Glimepiride 2 mg → Placebo → Glimepiride 4 mg, Glimepiride 4 mg → Glimepiride 2 mg → Placebo, Glimepiride 4 mg → Placebo → Glimepiride 2 mg, Placebo → Glimepiride 2 mg → Glimepiride 4 mg, Placebo → Glimepiride 4 mg → Glimepiride 2 mg

Primary outcome

Recovery Time From Hypoglycemia to Euglycemia
Time frame: From 1 to 180 minutes post hypoglycemic clamp
Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.
Rate of Recovery From Hypoglycemia to Euglycemia
Time frame: From 1 to 180 minutes post hypoglycemic clamp
The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.
Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery
Time frame: From 1 to 180 minutes post hypoglycemic clamp
The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.

Results and safety

Results posted to the registry on 24 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo → Glimepiride 2 mg → Glimepiride 4 mg	2	1
Glimepiride 2 mg → Glimepiride 4 mg → Placebo	1	1
Glimepiride 4 mg → Placebo → Glimepiride 2 mg	2	2
Placebo → Glimepiride 4 mg → Glimepiride 2 mg	2	0
Glimepiride 2 mg → Placebo → Glimepiride 4 mg	1	1
Glimepiride 4 mg → Glimepiride 2 mg → Placebo	2	1

Primary outcome: Recovery Time From Hypoglycemia to Euglycemia

Time frame: From 1 to 180 minutes post hypoglycemic clamp. Least squares mean (90% Confidence Interval). Unit: Minutes

Measure	Placebo n = 6	Glimepiride 2 mg n = 5	Glimepiride 4 mg n = 6
Value	74.49 (48.20 to 100.77)	88.90 (57.65 to 120.14)	109.81 (81.05 to 138.57)

Placebo vs Glimepiride 2 mg: Mean Difference (Final Values): 14.41 (90% CI -22.98 to 51.80)
Placebo vs Glimepiride 4 mg: Mean Difference (Final Values): 35.33 (90% CI -2.08 to 72.74)

Population analysed: The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.

Primary outcome: Rate of Recovery From Hypoglycemia to Euglycemia

Time frame: From 1 to 180 minutes post hypoglycemic clamp. Least squares mean (90% Confidence Interval). Unit: mg/dL/minute

Measure	Placebo n = 6	Glimepiride 2 mg n = 5	Glimepiride 4 mg n = 6
Value	0.32 (0.24 to 0.40)	0.22 (0.12 to 0.31)	0.19 (0.10 to 0.27)

Placebo vs Glimepiride 2 mg: Mean Difference (Final Values): -0.10 (90% CI -0.21 to 0.00)
Placebo vs Glimepiride 4 mg: Mean Difference (Final Values): -0.13 (90% CI -0.24 to -0.03)

Population analysed: The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.

Primary outcome: Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery

Time frame: From 1 to 180 minutes post hypoglycemic clamp. Least squares mean (90% Confidence Interval). Unit: mg/dL

Measure	Placebo n = 6	Glimepiride 2 mg n = 5	Glimepiride 4 mg n = 6
Value	22.61 (17.55 to 27.68)	17.58 (11.78 to 23.38)	15.34 (9.94 to 20.75)

Placebo vs Glimepiride 2 mg: Mean Difference (Final Values): -5.03 (90% CI -11.12 to 1.05)
Placebo vs Glimepiride 4 mg: Mean Difference (Final Values): -7.27 (90% CI -13.30 to -1.24)

Population analysed: The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.

Adverse events

Time frame: Up to 14 days after last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Glimepiride 2 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Glimepiride 4 mg	0 of 7 (0%)	4 of 7 (57.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Glimepiride 2 mg, Glimepiride 4 mg and Hypoglycemic Clamp in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 9 inclusion and 13 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 16 Aug 2018. 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 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.

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 24 Feb 2014). 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?

Recovery Time From Hypoglycemia to Euglycemia (time frame: From 1 to 180 minutes post hypoglycemic clamp). The study lists 3 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 NCT01614769.

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 16 Aug 2018.