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Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500

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ClinicalTrials.gov Identifier: NCT02212951
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Biodel

Brief Summary:
The study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: BIOD-531 Drug: Humalog Mix 75/25 Drug: Humulin R U-500 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin R U-500 and Humalog Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
Study Start Date : May 2014
Actual Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIOD-531 pre-meal
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
Drug: BIOD-531
Active Comparator: Humalog Mix 75/25 pre-meal
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
Drug: Humalog Mix 75/25
Active Comparator: Humulin R U-500
Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast
Drug: Humulin R U-500
Experimental: BIOD-531 post-meal
Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast
Drug: BIOD-531



Primary Outcome Measures :
  1. Post-standardized meal glucose exposure (AUC) [ Time Frame: 0-120 minutes after meal ]

Secondary Outcome Measures :
  1. Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) [ Time Frame: 0-720 minutes ]
  2. Insulin exposure (AUC) [ Time Frame: Various time frames over 720 minutes ]
  3. Maximal insulin concentration [ Time Frame: 0-720 minutes ]
  4. Post breakfast and post-lunch glucose exposure (AUC) [ Time Frame: Various times frames over 720 minutes ]
  5. Post-breakfast and post-lunch maximal glucose concentrations [ Time Frame: 0-720 minutes ]
  6. Injection site toleration (VAS and severity scales) [ Time Frame: 30 minutes post injection ]
  7. Draize injection site erythema and edema scoring [ Time Frame: 0-720 minutes ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • BMI > 25 kg/m2
  • Type 2 Diabetes Mellitus
  • HbA1c < 10.0%
  • Subject uses 50-200 units of insulin/day

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • History of bariatric surgery
  • Corticosteroid therapy
  • Significant cardiovascular or other major organ disease
  • Females who are breast feeding or pregnant
  • A sexually active person not using adequate contraceptive methods

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212951


Locations
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United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States
Sponsors and Collaborators
Biodel

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Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT02212951     History of Changes
Other Study ID Numbers: 3-152
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs