A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

Conditions

Type 2 Diabetes

Brief summary

Change from baseline in Hemoglobin A1c (HbA1c)

Detailed description

Change from Baseline in Weight, Percentage of Participants Who Achieve HbA1c <7%, Percentage of Participants Who Achieve HbA1c ≤6.5%, Percentage of Participants Who Achieve HbA1c <5.7%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥10%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥15%, A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia A composite endpoint defined as HbA1c ≤6.5%, weight loss ≥10%, and no hypoglycemia, defined as blood glucose <54 milligram/deciliter (mg/dL) (<3.0 millimole/liter [mmol/L]) and/or severe hypoglycemia, Change from Baseline in Fasting Serum Glucose, Change from Baseline in Waist Circumference, Change from Baseline in Body Mass Index (BMI), Change from Baseline in Impact of Weight on Quality of Life-Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Score

Related papers

No related papers found yet.

Interventions

DRUGPIOGLITAZONE

DRUGCANAGLIFLOZIN

DRUGGLUCAGON

DRUGLOPERAMIDE

DRUG-

DRUGCOLESEVELAM

DRUGDULAGLUTIDE

DRUGMETFORMIN

DRUGEMPAGLIFLOZIN

DRUGERTUGLIFLOZIN

DRUGDAPAGLIFLOZIN

DRUGBROMOCRIPTINE

DRUGTirzepatide

DRUGONDANSETRON

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in Hemoglobin A1c (HbA1c)	—

Secondary

Measure	Time frame
Change from Baseline in Weight, Percentage of Participants Who Achieve HbA1c <7%, Percentage of Participants Who Achieve HbA1c ≤6.5%, Percentage of Participants Who Achieve HbA1c <5.7%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥10%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥15%, A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia A composite endpoint defined as HbA1c ≤6.5%, weight loss ≥10%, and no hypoglycemia, defined as blood glucose <54 milligram/deciliter (mg/dL) (<3.0 millimole/liter [mmol/L]) and/or severe hypoglycemia, Change from Baseline in Fasting Serum Glucose, Change from Baseline in Waist Circumference, Change from Baseline in Body Mass Index (BMI), Change from Baseline in Impact of Weight on Quality of Life-Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Score	—

Measure

Time frame

Change from Baseline in Weight, Percentage of Participants Who Achieve HbA1c <7%, Percentage of Participants Who Achieve HbA1c ≤6.5%, Percentage of Participants Who Achieve HbA1c <5.7%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥10%, Percentage of Participants Who Achieve Weight loss from Baseline of ≥15%, A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia A composite endpoint defined as HbA1c ≤6.5%, weight loss ≥10%, and no hypoglycemia, defined as blood glucose <54 milligram/deciliter (mg/dL) (<3.0 millimole/liter [mmol/L]) and/or severe hypoglycemia, Change from Baseline in Fasting Serum Glucose, Change from Baseline in Waist Circumference, Change from Baseline in Body Mass Index (BMI), Change from Baseline in Impact of Weight on Quality of Life-Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Score

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Countries

Belgium, France, Germany, Romania

Outcome results

None listed