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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From 1 to 180 minutes post hypoglycemic clamp |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Snyposis Link | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo → Glimepiride 2 mg → Glimepiride 4 mg | 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. |
| FG001 | Glimepiride 2 mg → Glimepiride 4 mg → Placebo | 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. |
| FG002 | Glimepiride 4 mg → Placebo → Glimepiride 2 mg | 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. |
| FG003 | Placebo → Glimepiride 4 mg → Glimepiride 2 mg | 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. |
| FG004 | Glimepiride 2 mg → Placebo → Glimepiride 4 mg | 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. |
| FG005 | Glimepiride 4 mg → Glimepiride 2 mg → Placebo | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| 7-Day Washout |
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| Period 2 |
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| 7-Day Washout |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period. | Posted | Least Squares Mean | 90% Confidence Interval | Minutes | From 1 to 180 minutes post hypoglycemic clamp |
|
Up to 14 days after last dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo in a treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
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| 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. |
|
| 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. |
|
| Glimepiride 2 mg | Drug | One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods. |
|
| Glimepiride 4 mg | Drug | Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods. |
|
| Hypoglycemic Clamp | Procedure | 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. |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received 2 mg Glimepiride in a treatment period.
| OG002 | Glimepiride 4 mg | Participants received 4 mg Glimepiride in a treatment period. |
|
|
|
| Primary | 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. | The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL/minute | From 1 to 180 minutes post hypoglycemic clamp |
|
|
|
|
| Primary | 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. | The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | From 1 to 180 minutes post hypoglycemic clamp |
|
|
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Glimepiride 2 mg | Participants received 2 mg Glimepiride in a treatment period. | 0 | 6 | 2 | 6 |
| EG002 | Glimepiride 4 mg | Participants received 4 mg Glimepiride in a treatment period. | 0 | 7 | 4 | 7 |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D004700 | Endocrine System Diseases |
| Mean Difference (Final Values) |
| -0.13 |
| 2-Sided |
| 90 |
| -0.24 |
| -0.03 |
| Superiority or Other |
| Mean Difference (Final Values) |
| -7.27 |
| 2-Sided |
| 90 |
| -13.30 |
| -1.24 |
| Superiority or Other |