NCT02212951

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

August 7, 2014

Last Update Submit

January 15, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Post-standardized meal glucose exposure (AUC)

    0-120 minutes after meal

Secondary Outcomes (7)

  • Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)

    0-720 minutes

  • Insulin exposure (AUC)

    Various time frames over 720 minutes

  • Maximal insulin concentration

    0-720 minutes

  • Post breakfast and post-lunch glucose exposure (AUC)

    Various times frames over 720 minutes

  • Post-breakfast and post-lunch maximal glucose concentrations

    0-720 minutes

  • +2 more secondary outcomes

Study Arms (4)

BIOD-531 pre-meal

EXPERIMENTAL

Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast

Drug: BIOD-531

Humalog Mix 75/25 pre-meal

ACTIVE COMPARATOR

Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast

Drug: Humalog Mix 75/25

Humulin R U-500

ACTIVE COMPARATOR

Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast

Drug: Humulin R U-500

BIOD-531 post-meal

EXPERIMENTAL

Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast

Drug: BIOD-531

Interventions

BIOD-531DRUG
BIOD-531 post-mealBIOD-531 pre-meal
Humalog Mix 75/25DRUG
Humalog Mix 75/25 pre-meal
Humulin R U-500DRUG
Humulin R U-500

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 11, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Last Updated

February 8, 2016

Record last verified: 2016-01

Locations

US(1)