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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8521-004 | Other Identifier | Merck protocol number |
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This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide; Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000 mg/day).
The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent (AHA) washout period, if required; a 14-week blinded therapy period (which includes single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last dose of investigational product.
The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM with inadequate glycemic control on metformin monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8521 300 μg | Experimental | Participants receive double-blind MK-8521 300 μg daily (QD), subcutaneously, over 12 weeks. |
|
| MK-8521 180 μg | Experimental | Participants receive double-blind MK-8521 180 μg QD, subcutaneously, over 12 weeks. |
|
| Placebo | Placebo Comparator | Participants receive matching double-blind placebo, QD over 12 weeks. |
|
| Liraglutide 1.8 mg | Active Comparator | Participants receive open-label 1.8 mg of liraglutide, QD, subcutaneously, over 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8521 | Drug | Dose strengths: 180 μg QD administered subcutaneously. A 2-step dose escalation regimen [60 μg, 120 μg] over the first 2 weeks is used to achieve the final dose up to 180 μg.); 300 μg QD administered subcutaneously (A 3-step dose escalation regimen [60 μg, 120 μg, 180 μg] over the first 3 weeks is used to achieve the final dose up to 300 μg. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C. | Baseline and Week 12 |
| Number of Participants With an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to Week 14 |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to Week 12 |
| Number of Participants With an AE of Symptomatic Hypoglycemia | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events. | Up to Week 14 |
| Change From Baseline in Heart Rate at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight at Week 12 | This change from baseline reflects the Week 12 body weight minus the Week 0 body weight. | Baseline and Week 12 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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This study was conducted at 84 clinical trial sites in Australia, Colombia, Guatemala, Israel, Spain, New Zealand, and in the United States. Five hundred participants were screened and 176 randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-8521 180 μg | Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks. |
| FG001 | MK-8521 300 μg | Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks. |
| FG002 | Placebo | Participants receive matching double-blind placebo QD over 12 weeks. |
| FG003 | Liraglutide 1.8 mg | Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-8521 180 μg | Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks. |
| BG001 | MK-8521 300 μg | Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks. |
| 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 | Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C. | All randomized, treated participants with at least one A1C measurement (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 12 |
|
Up to Week 14
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all treated participants.
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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 | MK-8521 180 μg | Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 20.0 | 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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2016 | Feb 7, 2018 | Prot_SAP_000.pdf |
| 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 |
|---|---|
| D000069450 | Liraglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Placebo | Drug | Double dummy matching placebo for the MK-8521 and placebo arms: matching placebo for MK-8521 300 μg QD administered subcutaneously; matching placebo for MK-8521 180 μg QD administered subcutaneously. A dose escalation regimen consistent with that of the MK-8521 300 μg and 180 μg arms of the study; mock escalation will be performed over the first 2 to 3 weeks. |
|
| Liraglutide | Drug | Dose strength: 1.8 mg QD administered subcutaneously. A 2-step dose escalation regimen (0.6 mg, 1.2 mg) over the first 2 weeks is used to achieve the final dose up to 1.8 mg. |
|
|
| Metformin | Drug | Metformin immediate release (IR) or metformin extended release (XR) administered ≥1000 mg QD as background therapy |
|
This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate.
| Baseline and Week 12 |
This change from baseline reflects the Week 12 FPG minus the Week 0 FPG.
| Baseline and Week 12 |
| Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol. | Baseline and Week 12 |
| Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol. | Baseline and Week 12 |
| Change From Baseline in Fasting Triglycerides at Week 12 | This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides. | Baseline and Week 12 |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | This change from baseline reflects the Week 12 SBP minus the Week 0 SBP. | Baseline and Week 12 |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | This change from baseline reflects the Week 12 DBP minus the Week 0 DBP. | Baseline and Week 12 |
| Adverse Event |
|
| Death |
|
| Hyperglycemia Discontinuation Criteria |
|
| Lost to Follow-up |
|
| Non-Compliance With Study Drug |
|
| Screen Failure |
|
| Study Terminated by Sponsor |
|
| BG002 | Placebo | Participants receive matching double-blind placebo QD over 12 weeks. |
| BG003 | Liraglutide 1.8 mg | Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin A1C Classification by Levels | Hemoglobin A1C classification by levels: <8.5% or >=8.5% | Number | Participants |
|
| Antihyperglycemic agent (AHA) Washout Status | AHA washout status (yes/no). The trial included an 8-week AHA washout period for participants taking a AHA. | Number | Participants |
|
| Body Mass Index (BMI) | Number of participants with a BMI <30 kg/m^2 or BMI>=30 kg/m^2 | Number | Participants |
|
| Heart Rate | All randomized participants who had a baseline heart rate value. | Mean | Standard Deviation | Beats/minute |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Fasting Low Density Lipoprotein (LDL) Cholesterol | All randomized participants who had a baseline fasting LDL cholesterol value. | Mean | Standard Deviation | mg/dL |
|
| Fasting High Density Lipoprotein (HDL) Cholesterol | All randomized participants who had a baseline fasting HDL cholesterol value. | Mean | Standard Deviation | mg/dL |
|
| Fasting Triglycerides | All randomized participants who had a baseline fasting triglycerides value. | Mean | Standard Deviation | mg/dL |
|
| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mm Hg |
|
| Hemoglobin A1C | Mean | Standard Deviation | Percent |
|
| Body Weight | Mean | Standard Deviation | Kilograms |
|
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
| OG002 | Placebo | Participants receive matching double-blind placebo QD over 12 weeks. |
| OG003 | Liraglutide 1.8 mg | Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks. |
|
|
|
| Primary | Number of Participants With an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 14 |
|
|
|
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 12 |
|
|
|
| Primary | Number of Participants With an AE of Symptomatic Hypoglycemia | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 14 |
|
|
|
|
| Primary | Change From Baseline in Heart Rate at Week 12 | This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate. | All randomized, treated participants with at least one heart rate measurement (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | Beats/minute | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Body Weight at Week 12 | This change from baseline reflects the Week 12 body weight minus the Week 0 body weight. | All randomized, treated participants with at least one body weight measurement (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | Kilograms | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | This change from baseline reflects the Week 12 FPG minus the Week 0 FPG. | All randomized, treated participants with at least one FPG measurement (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol. | All randomized, treated participants with at least one fasting LDL cholesterol measurement (baseline or post-baseline). | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol. | All randomized, treated participants with at least one fasting HDL cholesterol measurement (baseline or post-baseline). | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Fasting Triglycerides at Week 12 | This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides. | All randomized, treated participants with at least one fasting triglycerides measurement (baseline or post-baseline). | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | This change from baseline reflects the Week 12 SBP minus the Week 0 SBP. | All randomized, treated participants with at least one SBP measurement (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | This change from baseline reflects the Week 12 DBP minus the Week 0 DBP. | All randomized, treated participants with at least one DBP measurement (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 12 |
|
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 18 |
| 46 |
| EG001 | MK-8521 300 μg | Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks. | 0 | 44 | 1 | 44 | 21 | 44 |
| EG002 | Placebo | Participants receive matching double-blind placebo QD over 12 weeks. | 1 | 43 | 1 | 43 | 15 | 43 |
| EG003 | Liraglutide 1.8 mg | Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks. | 0 | 42 | 0 | 42 | 13 | 42 |
| Death | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Difference in % vs Placebo |
| 2.2 |
| 2-Sided |
| 95 |
| -8.1 |
| 13.2 |
| Superiority |
| Miettinen & Nurminen method | 0.295 | Difference in % vs Liraglutide | -2.4 | 2-Sided | 95 | -12.4 | 5.5 | Superiority |
| Miettinen & Nurminen method | 0.587 | Difference in % vs Liraglutide | 2.2 | 2-Sided | 95 | -8.4 | 13.2 | Superiority |
| Difference in LS Means vs. Liraglutide |
| 3.84 |
| 2-Sided |
| 95 |
| 0.35 |
| 7.33 |
Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment |
| Superiority |
Longitudinal data analysis |
| Difference in LS Means vs. Placebo | 7.70 | 2-Sided | 95 | 4.17 | 11.23 | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | Superiority | Longitudinal data analysis |
| Difference in LS Means vs. Liraglutide | 4.65 | 2-Sided | 95 | 1.11 | 8.19 | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | Superiority | Longitudinal data analysis |
| Longitudinal data analysis |
Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment |
| 0.183 |
| Difference in Least Squares Means |
| 0.9 |
| 2-Sided |
| 95 |
| -0.4 |
| 2.2 |
| Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.010 | Difference in Least Squares Means | -1.8 | 2-Sided | 95 | -3.1 | -0.4 | Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.811 | Difference in Least Squares Means | -0.2 | 2-Sided | 95 | -1.5 | 1.2 | Superiority |
| Longitudinal data analysis | 0.018 | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | Difference in the Least Squares Means | -1.6 | 2-Sided | 95 | -2.9 | -0.3 | Superiority |
| Longitudinal data analysis |
Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment |
| 0.004 |
| Difference in Least Squares Means |
| 29.1 |
| 2-Sided |
| 95 |
| 9.7 |
| 48.6 |
| Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.004 | Difference in Least Squares Means | -29.5 | 2-Sided | 95 | -49.6 | -9.4 | Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.416 | Difference in Least Squares Means | 8.3 | 2-Sided | 95 | -11.7 | 28.2 | Superiority |
| Longitudinal data analysis | <0.001 | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | Difference in the Least Squares Means | -37.8 | 2-Sided | 95 | -57.5 | -18.0 | Superiority |
| Longitudinal data analysis |
Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment |
| 0.682 |
| Difference in Least Squares Means |
| -1.1 |
| 2-Sided |
| 95 |
| -6.2 |
| 4.1 |
| Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.344 | Difference in Least Squares Means | -2.5 | 2-Sided | 95 | -7.7 | 2.7 | Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.948 | Difference in Least Squares Means | 0.2 | 2-Sided | 95 | -5.0 | 5.4 | Superiority |
| Longitudinal data analysis | 0.306 | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | Difference in the Least Squares Means | -2.7 | 2-Sided | 95 | -7.8 | 2.5 | Superiority |
| Longitudinal data analysis |
Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment |
| 0.963 |
| Difference in Least Squares Means |
| -0.1 |
| 2-Sided |
| 95 |
| -3.3 |
| 3.2 |
| Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.394 | Difference in Least Squares Means | 1.4 | 2-Sided | 95 | -1.9 | 4.7 | Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.905 | Difference in Least Squares Means | -0.2 | 2-Sided | 95 | -3.5 | 3.1 | Superiority |
| Longitudinal data analysis | Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment | 0.325 | Difference in the Least Squares Means | 1.6 | 2-Sided | 95 | -1.6 | 4.9 | Superiority |