Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c).

Key facts

Study ID: NCT02794155
Run by: Diasome Pharmaceuticals
People needed: 157
Starts: 2016-06-01
Expected to finish: 2018-06-15
Last updated by the study team: 2018-07-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women ≥ 18 yrs. of age
Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months
Body Mass Index (BMI) ≤ 35 Kg/m2
Basal insulin includes insulin Glargine or insulin Detemir
Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin or rapid-acting analog at meals
HbA1c ≥ 7.0% and ≤ 10.5%
Fasting C-peptide ≤ 0.5 pmol/mL
Willingness to adhere to protocol and perform all required tests
Willing and able to review and sign the Informed Consent Form.
If child bearing age, must use acceptable form of birth control (ligation, 2 forms of birth control)
Willing to wear CGM devices and complete diaries.

You may not qualify if…

Total daily insulin dose ≥ 1.5 IU/kg/day.
History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect HbA1c measurements
Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy)
Patients who are selected to but are unwilling or unable to participate in the MRI evaluation subset. (These patients may still participate in the non-MRI subset).
Significant cardiovascular dysfunction or history within 12 months of Screening, eg, congestive heart failure (New York Heart Association Class III or IV), or clinically significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular heart disease including mild or greater aortic insufficiency, or moderate or greater mitral insufficiency; recurrent syncope, transient ischemic attacks, or cerebrovascular accident
Impaired liver function with elevated enzymes > 50% above the normal range at Screening. Patients with elevated liver enzymes may have the test repeated only at Visit 2 on a case-by-case basis at the request of the PI.
Creatinine level > 2 mg/dL for men, and > 1.8 mg/dL for women at Screening.
Patient on low carbohydrate diet, such as Atkins Diet
History of Adrenal supplementation within 3 years of Screening.
History of unawareness or SEVERE recurrent hypoglycemia, defined as a patient who is unaware of symptoms of hypoglycemia, or due to autonomic dysfunction, has no inherent warnings of hypoglycemia, and therefore requires outside assistance to rectify any episodes of hypoglycemia
Patients treated with systemic corticosteroids (Sporadic use of inhaled, intraarticular, and topical corticosteroids is not considered systemic).
Patients with triglyceride levels ≥500 mg/dL at Screening.
Patients with a history of cancer within the past 5 years, excluding basal or squamous cell carcinoma localized to the skin.
Epilepsy or other physical or medical conditions which could result in non-compliance with the study.
Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study
Unwilling to discontinue use of an insulin pump for the duration of the study.
Women who are pregnant, nursing, or planning to become pregnant during the course of the study.
Patients on NPH as their basal insulin.
Positive history of hepatitis A (within 12 months of Screening), or a positive history of hepatitis B, hepatitis C, or HIV at Screening.
History of drug addiction and/or alcohol abuse within 12 months of Screening.

Where it is running

Hope & Wellness Clinical Trials, Inc. — Corona, California, United States
National Research Institute — Los Angeles, California, United States
California Medical Research Associates Inc. — Northridge, California, United States
Bay Area Clinical Research — San Carlos, California, United States
Mills-Peninsula Health Services — San Mateo, California, United States
Orange County Research Center — Tustin, California, United States
Creekside Endocrine Associates, PC — Denver, Colorado, United States
Advanced Pharma CR, LLC — Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center — Ormond Beach, Florida, United States
Progressive Medical Research — Port Orange, Florida, United States
Atlanta Diabetes Associates — Atlanta, Georgia, United States
Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
Rocky Mountain Diabetes & Osteoporosis Center, PA — Idaho Falls, Idaho, United States
Associates in Endocrinology — Elgin, Illinois, United States
University of Massachusetts Memorial Hospital — Worcester, Massachusetts, United States
Desert Endocrinology Clinical Research Center — Henderson, Nevada, United States
SUNY Upstate Medical University — Syracuse, New York, United States
LION Research — Norman, Oklahoma, United States
Endocrine and Psychiatry Center — Houston, Texas, United States
Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
Rainier Clinical Research Center, Inc. — Renton, Washington, United States

Full record on ClinicalTrials.gov

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