Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

NCT01755416 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2012-503
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; closed loop; artificial pancreas; insulin; victoza; liraglutide

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone

  Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)

  0-1500 min

Study Arms (2)

Closed loop with sensor and Insulin

PLACEBO COMPARATOR

subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.

Drug: Closed loop with sensor and Insulin

Closed loop with sensor, Insulin and Liraglutide

ACTIVE COMPARATOR

Subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner, on Day 1.

Drug: Closed loop with sensor, Insulin and Liraglutide

Interventions

Closed loop with sensor and Insulin DRUG

Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.

Also known as: Novolog

Closed loop with sensor and Insulin

Closed loop with sensor, Insulin and Liraglutide DRUG

In this study visit the subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner on Day 1.

Also known as: Victoza

Closed loop with sensor, Insulin and Liraglutide

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age greater than 18 years and less than 40 years
• Have had diabetes for at least 1 year, and in good control (HbA1C \< 8.5 %)
• Be on continuous subcutaneous insulin infusion using an insulin pump
• Menstruating women must have negative pregnancy test.
• Hemoglobin (Hb) \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Medtronic: collaborator

Study Sites (1)

Albert Einstein College of Medicine West Campus CRC

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin; Insulin Aspart; Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones

Results Point of Contact

• Title: Dr. Rubina Heptulla
• Organization: Children's Hospital at Montefiore

rheptull@montefiore.org

718-920-7004

Study Officials

• Rubina A Heptulla, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Endocrinology

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: December 24, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 21, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-08

Locations

US (1)