Primary outcomeMean· 48 hours
Peak Post-prandial Venous Glucose Levels
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Closed Loop Insulin Delivery | 98 | 24 |
| Closed Loop + Liraglutide | 76 | 17 |
Trial · Interventional
CompletedEarly phase 1Results postedRegistry dataEffect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
NCTNCT01856790 (opens ClinicalTrials.gov in a new tab)Other id1211011156
Overview
- Status
- Completed
- Phase
- Early phase 1
- Enrollment
- 15 participants (actual)
- Sponsor
- Jennifer Sherr · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- Feb 2013
- Primary completion
- Nov 2015
- Completion
- Nov 2015
- First posted
- 17 May 2013 (estimated)
- Last update posted
- 30 Jan 2020
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2013201420152016
- Ph Early 1
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
NCT01856790Feb 2013 to Nov 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.
Interventions
- ePID closed loop systemDevice
- liraglutideDrug
Arms1
Experimental
Closed Loop Insulin Delivery
Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback. Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.
Primary outcomes1
Outcomes the sponsor listed as primary.
Peak Post-prandial Venous Glucose Levels
Time frame · 48 hours
Registry description
peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide
Secondary outcomes(1)
the Incremental Meal-related Glucose Area Under Curve (AUC)
Time frame · 5-hour post prandial period after breakfast, lunch, and dinner
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(7)
Secondary outcomeMean· 5-hour post prandial period after breakfast, lunch, and dinner
the Incremental Meal-related Glucose Area Under Curve (AUC)
| Group | Value (mg*hr/dL) | Spread |
|---|---|---|
| Closed Loop Insulin Delivery | 789 | 176 |
| Closed Loop + Liraglutide | 500 | 151 |
Other pre specified outcomeMean· 24- hours
Mean 24-hour Glucose Levels
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Closed Loop Insulin Delivery | 130 | 51 |
| Closed Loop + Liraglutide | 135 | 45 |
Other pre specified outcomeMean· 5- hour postprandial period
Mean Time to Peak Post-meal Glucose Value
| Group | Value (hours) | Spread |
|---|---|---|
| Closed Loop Insulin Delivery | 1.8 | 0.5 |
| Closed Loop + Liraglutide | 1.8 | 0.6 |
Other pre specified outcomeMean· 8a.m.-11p.m.
Mean Daytime Glucose Levels
| Group | Value (mg/dL) | Spread |
|---|---|---|
| ePID Closed Loop System Without Liraglutide | 143 | 55 |
| ePID Closed Loop System With Liraglutide | 146 | 47 |
Other pre specified outcomeMean· 5 hours
Incremental Glucagon Peak
| Group | Value (pg/mL/min) | Spread |
|---|---|---|
| Closed Loop Insulin Delivery | 29 | 16 |
| Closed Loop + Liraglutide | 35 | 20 |
Other pre specified outcomeMean· 2 hours
AUC Plasma Glucagon During MMTT
| Group | Value (pg*min/mL) | Spread |
|---|---|---|
| Closed Loop Insulin Delivery | 1904 | 651 |
| Closed Loop + Liraglutide | 1801 | 906 |
Other pre specified outcomeMean· 24 hours
Differences in Daily Insulin Requirements
| Group | Value (units) | Spread |
|---|---|---|
| Pre-Liraglutide Treatment | 51.5 | 14 |
| Post-Liraglutide Treatment | 37.5 | 12.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Closed Loop OnlyEach participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback | – | 0 / 13 | 0 / 13 |
| Closed Loop + LiraglutideFollowing the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. | – | 0 / 11 | 6 / 11 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 40 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. age 18-40 years
2. clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
3. duration of T1D ≥ 1 year
4. HbA1c ≤ 9 %
5. Treated with CSII for at least 3 months
6. Body weight \> 50 kg (to accommodate phlebotomy)
7. Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct
Exclusion Criteria:
1. Insulin resistant (defined as requiring \> 1.5 units/kg/day at time of study enrollment)
2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
3. Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
4. History of hypoglycemic seizure within last 3 months
5. Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
7. History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
8. Taking a medication known to affect gastric motility
9. History of pancreatitis, gallstones, alcoholism or high triglyceride levels
10. Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
11. Subjects unable to give consent
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