Phase 2
Completed N=18
Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
Source: ClinicalTrials.gov NCT01755416 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone — 159.7; 144.6 mg/dl
Summary
Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic excursions than insulin mono-therapy.
Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition of Liraglutide compared to insulin mono-therapy.
Study Design: This is a randomized open labeled crossover design trial comparing adjuvant Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for insulin delivery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone |
159.7; 144.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years and less than 40 years
- Have had diabetes for at least 1 year, and in good control (HbA1C 12 g/dL
- Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Screening:
a. Oral contraceptives (female subjects)b. Antihypertensive agents c. Lipid-lowering agents d. Thyroid replacement therapy e. Antidepressant agents
- For female subjects: a. Not breastfeeding b. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [βhCG])at Screening c. If of childbearing potential, must practice and be willing to continue to practice appropriate birth control (defined as at least one method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectable's, hormonal contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation or occlusion, or a vasectomized partner)during the entire duration of the study and must not be planning to conceive
- Should not have any alcohol or drug dependency as assessed by CRAFFT questionnaire.
Exclusion Criteria
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc., that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis
- Hemoglobin less than 12 g/dl
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
- HbA1c > 8.5 %
- Weight less than 50 Kg
- History of gastro paresis and on medications that alter gastric emptying
- History of Pancreatitis and impaired renal function
- Hypoglycemic unawareness
- History of sensitivity to 5-HT3 receptor antagonists
- History of QT prolongation or any known cardio-vascular disease
- Concomitant use of both Acetaminophen and vitamin C
- Patients on glucocorticoid therapy
- Known allergy to Liraglutide
- Personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia (MEN) syndrome type 2.
Data sourced from ClinicalTrials.gov (NCT01755416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.