Change in Beta-hydroxybutyrate Levels in Blood
| Group | Value (mM) | Spread |
|---|---|---|
| Placebo Arm: | -0.23 | 0.17 |
| Dapagliflozin Arm: | 0.63 | 0.22 |
| Exenatide Extended Release Arm: | 0.24 | 0.21 |
| Exenatide Extended Release & Dapagliflozin Arm: | 0.31 | 0.19 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes
NCT029624921 Nov 2016 to 24 Oct 2021
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.
Active comparator
Dapagliflozin Arm:
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Active comparator
Exenatide extended release Arm:
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Placebo comparator
Placebo Arm:
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Active comparator
Exenatide extended release & dapagliflozin Arm:
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Outcomes the sponsor listed as primary.
Change in Beta-hydroxybutyrate Levels in Blood
Time frame · 12 weeks
Beta-hydroxybutyrate (BHB) was measured in blood during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.
Change in HbA1c Following Treatment
Time frame · 12 weeks
Hemoglobin A1c (HbA1c) was measured in basal conditions in all the groups at week 0 and week 12 of treatment. The change in HbA1c from baseline at 12 weeks is calculated as: HbA1c at week 12 - HbA1c at week 0.
Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment
Time frame · 12 weeks
Beta-hydroxybutyrate (BHB) was measured in urine during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.
Change in Plasma Glucagon
Time frame · 12 weeks
change in basal plasma glucagon after 12 weeks of dapagliflozin and Bydureon or combination of both treatments compared to baseline
Change in Total Insulin Dose
Time frame · 12 weeks
change in total (basal or long acting and short acting) insulin daily dose calculated as daily units/Kg body weight at 12 weeks from baseline (0 week). Long acting or basal insulin dose (in units of insulin) plus short acting (meal) insulin doses administered through the day and reported by patients in patients logs or from insulin pumps are added and divided by body weight in Kg. The reported total insulin dose/Kg represents the average of last 3-7 days before the visit.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mM) | Spread |
|---|---|---|
| Placebo Arm: | -0.23 | 0.17 |
| Dapagliflozin Arm: | 0.63 | 0.22 |
| Exenatide Extended Release Arm: | 0.24 | 0.21 |
| Exenatide Extended Release & Dapagliflozin Arm: | 0.31 | 0.19 |
| Group | Value (Percent of Hemoglobin (%)) | Spread |
|---|---|---|
| Dapagliflozin Arm: | -0.3 | 0.1 |
| Exenatide Extended Release Arm: | -0.4 | 0.2 |
| Placebo Arm: | -0.1 | 0.1 |
| Exenatide Extended Release & Dapagliflozin Arm: | -0.9 | 0.1 |
| Group | Value (mM) | Spread |
|---|---|---|
| Placebo Arm: | 1.2 | 0.5 |
| Dapagliflozin Arm: | 0.4 | 0.2 |
| Exenatide Extended Release Arm: | -0.7 | 0.6 |
| Exenatide Extended Release & Dapagliflozin Arm: | 1.1 | 0.4 |
| Group | Value (pg/ml) | Spread |
|---|---|---|
| Placebo Arm: | 2 | 2 |
| Dapagliflozin Arm: | 16 | 10 |
| Exenatide Extended Release Arm: | -15 | 8 |
| Exenatide Extended Release & Dapagliflozin Arm: | -10 | 6 |
| Group | Value (Units/Kg) | Spread |
|---|---|---|
| Placebo Arm: | -0.01 | 0.02 |
| Dapagliflozin Arm: | -0.02 | 0.02 |
| Exenatide Extended Release Arm: | -0.05 | 0.02 |
| Exenatide Extended Release & Dapagliflozin Arm: | -0.04 | 0.02 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo Arm:dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection) Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks | 0 / 11 | 0 / 11 | 0 / 11 |
| Dapagliflozin Arm:dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection) Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks | 0 / 15 | 0 / 15 | 0 / 15 |
| Exenatide Extended Release Arm:subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks | 0 / 15 | 0 / 15 | 0 / 15 |
| Exenatide Extended Release & Dapagliflozin Arm:Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks | 0 / 21 | 0 / 21 | 0 / 21 |
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