Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.

Browse trials for

• Diabetes Mellitus, Type 1 3,614
• Overweight 3,767
• Obesity 6,570

Keywords

• Randomized
• Double-blinded
• Parallel controlled
• semaglutide

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.

Study arms

• Experimental
  Semaglutide

  Participants will receive semaglutide via subcutaneous injection once a week for 24 weeks. Dosing will begin at 0.25 mg and will be increased every 4 weeks, to a maximum of 2.4 mg, if tolerated.

  Drug: Semaglutide

• Placebo comparator
  Placebo

  Participants will receive a 0.9% normal saline placebo via subcutaneous injection once a week for 24 weeks. Dosing will begin at 0.25 mg and increase every 4 weeks until a maximum of 2.4 mg.

  Drug: Placebo

Interventions

• DrugSemaglutide

  Semaglutide will be administered subcutaneously once a week for 24 weeks. The starting dose will be 0.25 mg, with increases every 4 weeks to 0.5 mg, 1.0 mg, 1.7 mg, and up to 2.4 mg. Dose can be de-escalated or not escalated based on participant symptoms, preference, or clinician judgement.

• DrugPlacebo

  A 0.9% normal saline placebo will be administered subcutaneously weekly for 24 weeks. The starting dose will be 0.25 mg, with increases every 4 weeks to 0.5 mg, 1.0 mg, 1.7 mg, and up to 2.4 mg.

  Also known as: 0.9% normal saline

Primary outcomes

1. Change in lean mass

   Change in total lean mass, measured in kilograms (kg).

   Time frame: Baseline to 24 weeks of study drug use

Secondary outcomes

1. Fat mass (kilograms)

   Change in total fat mass measured in kilograms (kg) using dual-energy X-ray absorptiometry (DEXA).

   Time frame: Baseline to 24 weeks

2. Proportion of lean mass to fat mass (percentage)

   Change in the proportion of lean mass relative to fat mass as a percentage (%), measured using dual-energy X-ray absorptiometry (DEXA).

   Time frame: Baseline to 24 weeks

3. Bone density (grams per cubic centimetre)

   Change in bone density measured in grams per cubic centimetre (g/cm³) using dual-energy X-ray absorptiometry (DEXA).

   Time frame: Baseline to 24 weeks

4. Appendicular lean mass and visceral fat mass (kilograms)

   Change in appendicular lean mass and visceral fat mass measured in kilograms (kg) using dual-energy X-ray absorptiometry (DEXA).

   Time frame: Baseline to 24 weeks

5. Weight (kilograms)

   Change in body weight, measured in kilograms (kg), on an electronic scale.

   Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

6. Hip circumference (centimetres)

   Change in hip circumference, measured in centimetres (cm). Use a measuring tape to measure the largest circumference around the buttock area.

   Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

7. Waist circumference (centimetres)

   Change in waist circumference, measured in centimetres (cm) using anthropometric measurements. Use a measuring tape to measure at the level of the ischial crests as a landmark.

   Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

8. Blood pressure (millimeters of mercury)

   Change in blood pressure, measured in millimetres of mercury (mmHg), after a 5-minute reset, measured 3 times. We will average the 3 values.

   Time frame: Baseline to 24 weeks

9. Mean peak torque

   Change in mean peak torque during isokinetic and isometric knee extension/flexion, measured via Biodex. Results will be recorded as weight-based torque (Nm/kg).

   Time frame: Baseline to 24 weeks

10. Handgrip strength test

    Change in maximum handgrip strength for the dominant and non-dominant hands, measured in kilograms (kg) using a hand dynamometer.

    Time frame: Baseline to 24 weeks

11. Six-minute walk test (distance in metre)

    Change in the distance walked during the six-minute walk test (6MWT), measured in metres (m).

    Time frame: Baseline to 24 weeks

12. General physical activity (steps/day)

    Change in average number of steps per day measured using an accelerometer.

    Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

13. Time spent in different intensities of physical activity

    Change in time spent in light, moderate, and vigorous physical activity, measured in minutes per day using an accelerometer.

    Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

14. Mean total energy consumed per day

    Change in mean total energy consumed per day, measured in kilocalories (kcals), using Keenoa. Keenoa - Food diary smartphone application

    Time frame: Baseline to midpoint to 24 weeks

15. Mean total carbohydrates/fat/protein

    Change in mean daily intake of carbohydrates, fat, and protein, measured in grams per day (g/day) and as a proportion of energy, using Keenoa. Keenoa - Food diary smartphone application

    Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

16. Three-factor eating questionnaire R-18 scores

    Change in the Three-Factor Eating Questionnaire (TFEQ-R18) is an 18-item validated questionnaire regarding eating behaviour and restraint, including subscores of uncontrolled eating, cognitive restraint, and emotional eating.

    Time frame: Baseline to 24 weeks

17. Canadian Food Intake Screener score

    Change in the Canadian Food Intake Screener score (CFIS): a 16-item survey assessing healthy eating habits in relation to the Canadian Food Guide

    Time frame: Baseline to 24 weeks

18. Modified Hypoglycemia Fear Survey II (mHFS-II).

    A survey validated in type 1 diabetes to quantify fear of hypoglycemia based on a 5-point Likert scale, with higher scores associated with worsened fear of hypoglycemia. There are 2 subscales: i) HFS-Fear and ii) HFS-Behaviour. This has a total of 32 items.

    Time frame: Baseline to 24 weeks

19. Diabetes Distress Scale (DDS).

    A 17-item survey to quantify diabetes distress based on a 6-point Likert scale, with higher points associated with worsened diabetes distress. A mean item score of 2.0-2.9 signifies moderate distress, whereas a mean item score ≥ 3.0 signifies high distress.

    Time frame: Baseline to 24 weeks

20. Diabetes Quality-of-Life Brief Clinical Inventory (DQOLBCI).

    A 15-item survey validated in type 1 diabetes to assess quality of life reflective of treatment satisfaction. It is based on a 5-point Likert scale, with lower scores reflective of better

    Time frame: Baseline to 24 weeks

21. Change in individual Continuous Glucose Monitoring metrics

    * Time spent between 3.9-10 millimoles per litre (Time in Range) as % * Time spent \< 3.9 millimoles per litre (mmol/L) (Time below Range) as % * Time spent above 10 millimoles per litre (mmol/L) (Time above range) as %

    Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks

22. Glycated hemoglobin

    Measure of average glucose control over the last 3-4 months (in keeping with the lifespan of red blood cells), with a target of \< 7 percent. Measured as %.

    Time frame: Baseline to midpoint (15-16 weeks) and 24 weeks

23. Mean daily insulin requirements

    Mean daily insulin requirements, including total, basal and bolus.

    Time frame: Baseline to midpoint (15-16 weeks) and 24 weeks

24. Lipid levels

    Total cholesterol, Low-Density Lipoprotein-cholesterol, High-Density Lipoprotein-cholesterol, triglycerides (mmol/L)

    Time frame: Baseline to 24 weeks

Other outcomes

1. Exercise sub-study: glucose levels

   Differences in continuous glucose metrics (within 2 hours and 24 hours), between semaglutide and placebo for a) resistance training and b) aerobic training.

   Time frame: Week 26-27 of study drug use

2. Exercise sub-study: insulin needs

   Insulin requirements over 24 hours between semaglutide and placebo for a) resistance training and b) aerobic training.

   Time frame: week 26-27

3. Number of episodes of severe hypoglycemia (safety outcome)

   Number of episodes of severe hypoglycemia * Requiring emergency room visit * Requiring hospitalization * Not requiring medical attention

   Time frame: Baseline to 24 weeks

4. Number of episodes of ketone levels ≥ 1.5 millimoles per liter (safety outcome)

   Number of episodes with ketone levels ≥ 1.5 millimoles per litre (mmol/L). * Requiring an emergency room visit * Requiring hospitalization * Diagnosed with diabetic ketoacidosis

   Time frame: Baseline to 24 weeks

5. Gastrointestinal side effects (safety outcome)

   Gastrointestinal side effects * Gallbladder disease * Acute pancreatitis * Rise in liver enzymes

   Time frame: Baseline to 24 weeks

6. Diabetic retinopathy (safety outcome)

   Diabetic retinopathy * New * Progression * Sight-threatening

   Time frame: Baseline to 24 weeks

7. Serum creatinine (safety outcome)

   Rise in creatinine (micromol/L)

   Time frame: Baseline to midway to 24 weeks

8. Urine albumin: creatinine ratio (safety outcome

   Change in albuminuria (mg/mmol)

   Time frame: Baseline to midway to 24 weeks

9. Liver enzymes

   Change in liver enzymes (alanine aminotransferase and alkaline phosphatase, Units/L

   Time frame: Baseline to midway to 24 week

Individual participant data

Plan to share: Undecided — Sharing would be case-by-case basis to protect the anonymity of participants and to ensure it is for non-commercial use.