Primary outcomeMean· 12 Weeks
Change in Mean Weekly Glucose Concentrations
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Placebo | 1 | 0 |
| Liraglutide 1.8mg | -10 | 1 |
| Liraglutide 1.2mg | -10 | 2 |
| Liraglutide 0.6 mg | -0.3 | 2 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataLiraglutide in the Treatment of Type 1 Diabetes Mellitus
NCTNCT01722266 (opens ClinicalTrials.gov in a new tab)Other idNN1962
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 72 participants (actual)
- Sponsor
- University at Buffalo · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 1 Nov 2012
- Primary completion
- 1 Apr 2014
- Completion
- 1 Dec 2014
- First posted
- 6 Nov 2012 (estimated)
- Last update posted
- 5 Jan 2024
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2012201320142015
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting, postprandial and the overall mean glucose concentrations. Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In addition, the time spent at glucose concentrations \>150 and 200mg/dl and \<70 and \<40 mg/dl will also be compared. Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose concentrations will be measured as areas under the curve for the data obtained from the meal challenge. Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases postprandial glucagon concentrations and increases postprandial C-peptide concentrations. Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying. Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.
Interventions
- LiraglutideDrug
- PlaceboDrug
Arms4
Placebo comparator
Placebo
Daily Injection
Active comparator
Liraglutide 1.8mg
Daily Injection
Active comparator
Liraglutide 1.2mg
Daily injections
Active comparator
Liraglutide 0.6 mg
Daily injection
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Mean Weekly Glucose Concentrations
Time frame · 12 Weeks
Registry description
The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.
Secondary outcomes(6)
Change in HbA1c
Time frame · 12 Weeks
Registry description
Change from baseline (week 0) in HbA1c at 12 weeks after treatment
Change in Body Weight From Baseline
Time frame · 12 weeks
Registry description
Change in Body weight in Kg from baseline after 12 weeks of treatment
Change in Total Insulin Dose From Baseline
Time frame · 12 weeks
Registry description
Total daily insulin dose = Basal insulin dose plus bolus insulin dose. Change from baseline in Total daily insulin dose at 12 weeks from treatment.
Change in the Area Under Curve (AUC) of Glucose Following the Meal
Time frame · 12 weeks
Registry description
Change in the Area Under Curve (AUC0h-5h) of glucose concentration measured following meal challenge of up to 5hrs performed at baseline (week 0) at 12 weeks following treatment.
Change in Carbohydrate Intake
Time frame · 12 weeks
Registry description
Change from baseline (0 week) in Daily Carbohydrate intake (in grams) at 12 weeks after treatment.
Change in Glucagon Concentrations
Time frame · 12 weeks
Registry description
change from baseline (week 0) in glucagon concentrations following 12 weeks of treatment
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· 12 Weeks
Change in HbA1c
| Group | Value (Percent of Hemoglobin (%)) | Spread |
|---|---|---|
| Placebo | -0.30 | 0.15 |
| Liraglutide 1.8mg | -0.42 | 0.15 |
| Liraglutide 1.2mg | -0.78 | 0.15 |
| Liraglutide 0.6 mg | -0.26 | 0.17 |
Secondary outcomeMean· 12 weeks
Change in Body Weight From Baseline
| Group | Value (Kg) | Spread |
|---|---|---|
| Placebo | -0.3 | 0.5 |
| Liraglutide 1.8mg | -4.8 | 0.7 |
| Liraglutide 1.2mg | -5.0 | 1.2 |
| Liraglutide 0.6 mg | -2.7 | 0.6 |
Secondary outcomeMean· 12 weeks
Change in Total Insulin Dose From Baseline
| Group | Value (Units of insulin) | Spread |
|---|---|---|
| Placebo | -3.4 | 0.7 |
| Liraglutide 1.8mg | -10 | 0.5 |
| Liraglutide 1.2mg | -12.1 | 0.7 |
| Liraglutide 0.6 mg | -2.8 | 0.7 |
Secondary outcomeMean· 12 weeks
Change in the Area Under Curve (AUC) of Glucose Following the Meal
| Group | Value (g * 5 h * dL^-1) | Spread |
|---|---|---|
| Placebo | 0.04 | 0 |
| Liraglutide 1.8mg | -0.55 | 10 |
| Liraglutide 1.2mg | -0.55 | 10 |
| Liraglutide 0.6 mg | -0.01 | 0.11 |
Secondary outcomeMean· 12 weeks
Change in Carbohydrate Intake
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo | -13.4 | 2.6 |
| Liraglutide 1.8mg | -46.4 | 1.6 |
| Liraglutide 1.2mg | -47.6 | 2.6 |
| Liraglutide 0.6 mg | -23.7 | 2.5 |
Secondary outcomeMean· 12 weeks
Change in Glucagon Concentrations
| Group | Value (ng/L) | Spread |
|---|---|---|
| Placebo | 5 | 3 |
| Liraglutide 1.8mg | 9 | 6 |
| Liraglutide 1.2mg | -6 | 9 |
| Liraglutide 0.6 mg | 7 | 4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboDaily Injection Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter. Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards. | – | 0 / 17 | 3 / 17 |
| Liraglutide 1.8mgDaily Injection Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter. Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards. | – | 0 / 15 | 9 / 15 |
| Liraglutide 1.2mgDaily injections Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter. Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards. | – | 0 / 13 | 10 / 13 |
| Liraglutide 0.6 mgDaily injection Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter. Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards. | – | 0 / 18 | 11 / 18 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies10
Studies that cite this trial.
Studies with results
5 studies on this page
Indexing hint: Randomized controlled trial · 2016
16 results
Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks.
Kuhadiya et al. 2016Diabetes carecited by 84
PMID 27208343PMC5864130DOI 10.2337/dc15-1136PUB-27208343
Rights unknown16 results
PubMed tag: none · 2011
14 results
Durability of effects of exenatide treatment on glycemic control, body weight, systolic blood pressure, C-reactive protein, and triglyceride concentrations.
Varanasi et al. 2011Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 30
PMID 20841306DOI 10.4158/ep10199.orPUB-20841306
Full text at the publisher14 results
PubMed tag: none · 2010
9 results
Effects of exenatide on systolic blood pressure in subjects with type 2 diabetes.
Okerson et al. 2010American journal of hypertensioncited by 139
PMID 20019672DOI 10.1038/ajh.2009.245PUB-20019672
Rights unknown9 results
Indexing hint: Randomized controlled trial · 2009
6 results
Effects of exenatide alone and in combination with daclizumab on beta-cell function in long-standing type 1 diabetes.
Rother et al. 2009Diabetes carecited by 103
PMID 19808924PMC2782986DOI 10.2337/dc09-0773PUB-19808924
Free to read · publisher termsCC BY-NC-ND6 results
Indexing hint: Randomized controlled trial · 2007
13 results
Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Buse et al. 2007Clinical therapeuticscited by 194
PMID 17379054DOI 10.1016/j.clinthera.2007.01.015PUB-17379054
Full text at the publisher13 results
More studies
5 studies on this page
PubMed tag: none · 2013
Liraglutide as additional treatment to insulin in obese patients with type 1 diabetes mellitus.
Kuhadiya et al. 2013Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 59
PMID 23807520DOI 10.4158/ep13065.orPUB-23807520
Full text at the publisher
PubMed tag: none · 2012
Clinical use of liraglutide in type 2 diabetes and its effects on cardiovascular risk factors.
Varanasi et al. 2012Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 36
PMID 21856595DOI 10.4158/ep11169.orPUB-21856595
Full text at the publisher
PubMed tag: none · 2011
Liraglutide as additional treatment for type 1 diabetes.
Varanasi et al. 2011European journal of endocrinologycited by 90
PMID 21646283DOI 10.1530/eje-11-0330PUB-21646283
Full text at the publisher
Indexing hint: Review · 2010
Adjunct therapy for type 1 diabetes mellitus.
Lebovitz et al. 2010Nature reviews. Endocrinologycited by 39
PMID 20404854DOI 10.1038/nrendo.2010.49PUB-20404854
Full text at the publisher
Indexing hint: Review · 2009
A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus.
Montanya et al. 2009Clinical therapeuticscited by 85
PMID 20109994DOI 10.1016/j.clinthera.2009.11.034PUB-20109994
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Patients with type 1 diabetes mellitus: Fasting c-peptide \< 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis.
2. Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily
3. HbA1c of less than 8.5%.
4. Well versed with carbohydrate counting
5. Age 18-75 years
Exclusion Criteria:
1. Type 1 diabetes for less than 12 months;
2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
3. Hepatic disease (transaminase \> 3 times normal) or cirrhosis;
4. Renal impairment (serum creatinine \> 1.5);
5. HIV or Hepatitis C positive status;
6. Participation in any other concurrent clinical trial;
7. Any other life-threatening, non-cardiac disease;
8. Use of an investigational agent or therapeutic regimen within 30 days of study.
9. history of pancreatitis
10. pregnancy
11. inability to give informed consent
12. history of gastroparesis
13. history of medullary thyroid carcinoma or MEN 2 syndrome.
14. Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
15. Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant
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