Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes.

Kuhadiya ND, Ghanim H, Mehta A, Garg M, Khan S, Hejna J, Torre B, Makdissi A, Chaudhuri A, Batra M, Dandona P

The Journal of clinical endocrinology and metabolism4 Aug 2016Cited by 52 (Europe PMC)

PMID27490915DOI10.1210/jc.2016-1451PepBankPUB-27490915

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone10

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

01HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on liraglutide and insulin, adding dapagliflozin lowered HbA1c versus placebo.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, adding dapagliflozin lowered HbA1c more than placebo.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change after 12 weeks
Study
n = 30
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c fall
0.66%
dapagliflozin
Source sentences
Summary
In the dapagliflozin group, glycated hemoglobin fell by 0.66% ± 0.08% from 7.8% ± 0.21% (P < .01 vs placebo), whereas it did not change significantly in the placebo group from 7.40% ± 0.20% to 7.30% ± 0.20%.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091501
02HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on liraglutide and insulin, adding dapagliflozin reduced body weight versus placebo.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, adding dapagliflozin lowered body weight more than placebo.
Peptide
Liraglutide
Outcome
DecreaseBody weight change
Study
n = 30
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Measurements
Body weight fall
1.9 kg
dapagliflozin
Source sentences
Summary
The body weight fell by1.9 ± 0.54kg (P < .05 vs placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091502
03HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes on liraglutide and insulin, adding dapagliflozin caused no additional hypoglycemia versus placebo.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, adding dapagliflozin did not cause more low blood sugar than placebo.
Peptide
Liraglutide
Outcome
No significant changeHypoglycemia
Study
n = 30
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
There was no additional hypoglycemia (blood glucose < 3.88 mmol/L; P = .52 vs placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091503
04HumanNot a test of Liraglutide aloneRandomized controlled trialMechanism
In adults with type 1 diabetes on liraglutide and insulin, dapagliflozin increased plasma glucagon.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, dapagliflozin raised blood glucagon levels.
Peptide
Liraglutide
Outcome
IncreasePlasma glucagon
Study
n = 30
Comparator
Placebo
Outcome group
Receptor activity and mechanism · Endocrine and hormones
Measurements
Glucagon increase
35%
dapagliflozin
Source sentences
Summary
In the dapagliflozin group, there were significant increases in the plasma concentrations of glucagon by 35% ± 13% (P < .05), hormone-sensitive lipase by 29% ± 11% (P < .05), free fatty acids by 74% ± 32% (P < .05), acetoacetate by 67% ± 34% (P < .05), and β-hydroxybutyrate by 254% ± 81% (P < .05).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091504
05HumanNot a test of Liraglutide aloneRandomized controlled trialMechanism
In adults with type 1 diabetes on liraglutide and insulin, dapagliflozin increased plasma hormone-sensitive lipase.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, dapagliflozin raised a blood fat-breakdown enzyme.
Peptide
Liraglutide
Outcome
IncreasePlasma hormone-sensitive lipase
Study
n = 30
Comparator
Placebo
Outcome group
Receptor activity and mechanism · Metabolic and weight
Measurements
Hormone-sensitive lipase increase
29%
dapagliflozin
Source sentences
Summary
In the dapagliflozin group, there were significant increases in the plasma concentrations of glucagon by 35% ± 13% (P < .05), hormone-sensitive lipase by 29% ± 11% (P < .05), free fatty acids by 74% ± 32% (P < .05), acetoacetate by 67% ± 34% (P < .05), and β-hydroxybutyrate by 254% ± 81% (P < .05).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091505
06HumanNot a test of Liraglutide aloneRandomized controlled trialMechanism
In adults with type 1 diabetes on liraglutide and insulin, dapagliflozin increased plasma free fatty acids.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, dapagliflozin raised blood free fatty acids.
Peptide
Liraglutide
Outcome
IncreasePlasma free fatty acids
Study
n = 30
Comparator
Placebo
Outcome group
Receptor activity and mechanism · Metabolic and weight
Measurements
Free fatty acids increase
74%
dapagliflozin
Source sentences
Summary
In the dapagliflozin group, there were significant increases in the plasma concentrations of glucagon by 35% ± 13% (P < .05), hormone-sensitive lipase by 29% ± 11% (P < .05), free fatty acids by 74% ± 32% (P < .05), acetoacetate by 67% ± 34% (P < .05), and β-hydroxybutyrate by 254% ± 81% (P < .05).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091506
07HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes on liraglutide and insulin, dapagliflozin increased plasma acetoacetate.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, dapagliflozin raised blood ketone acetoacetate.
Peptide
Liraglutide
Outcome
IncreasePlasma acetoacetate
Study
n = 30
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Acetoacetate increase
67%
dapagliflozin
Source sentences
Summary
In the dapagliflozin group, there were significant increases in the plasma concentrations of glucagon by 35% ± 13% (P < .05), hormone-sensitive lipase by 29% ± 11% (P < .05), free fatty acids by 74% ± 32% (P < .05), acetoacetate by 67% ± 34% (P < .05), and β-hydroxybutyrate by 254% ± 81% (P < .05).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091507
08HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes on liraglutide and insulin, dapagliflozin increased plasma beta-hydroxybutyrate.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, dapagliflozin raised the blood ketone beta-hydroxybutyrate.
Peptide
Liraglutide
Outcome
IncreasePlasma beta-hydroxybutyrate
Study
n = 30
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Beta-hydroxybutyrate increase
254%
dapagliflozin
Source sentences
Summary
In the dapagliflozin group, there were significant increases in the plasma concentrations of glucagon by 35% ± 13% (P < .05), hormone-sensitive lipase by 29% ± 11% (P < .05), free fatty acids by 74% ± 32% (P < .05), acetoacetate by 67% ± 34% (P < .05), and β-hydroxybutyrate by 254% ± 81% (P < .05).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091508
09HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes on liraglutide and insulin, dapagliflozin increased urinary ketone levels.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, dapagliflozin raised ketones in urine.
Peptide
Liraglutide
Outcome
IncreaseUrinary ketone levels
Study
n = 30
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Urinary ketone levels also increased significantly (P < .05).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091509
10HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes on liraglutide and insulin, two patients in the dapagliflozin group developed diabetic ketoacidosis.
In plain wordsIn adults with type 1 diabetes already using liraglutide and insulin, two patients given dapagliflozin developed diabetic ketoacidosis.
Peptide
Liraglutide
Outcome
IncreaseDiabetic ketoacidosis
Study
n = 30
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Diabetic ketoacidosis
2 patients
dapagliflozin
Source sentences
Summary
Two patients in the dapagliflozin group developed diabetic ketoacidosis.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants included T1D patients on liraglutide therapy for at least last 6 months.
Summary · context
Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2749091510

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02518945