Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes (Samba-02)

March 17, 2016 updated by: Dance Biopharm Inc.

Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes

Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS).

The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
  • Body mass index 25-40 kg/m2
  • Hemoglobin A1c 6.5-9.5%
  • Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
  • Fasting c-peptide less than 1 nmol/L

Exclusion Criteria:

  • Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.
  • Active or chronic pulmonary disease.
  • Any major disorder other than type 2 diabetes.
  • Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
  • Proliferative retinopathy or maculopathy or severe neuropathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INH 69 U (low)
single 69 U dose administration of Dance inhaled human insulin using a low-concentration formulation (300 U/mL)
Drug: INH 69 U (low)
inhaled human insulin
Other Names:
  • Dance-501
Experimental: INH 69 U (high)
single 69 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)
Drug: INH 69 U (high)
inhaled human insulin
Other Names:
  • Dance-501
Experimental: INH 139 U
single 139 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) This arm was repeated in order to evaluate intra-subject variability.
Drug: INH 139 U
inhaled human insulin
Other Names:
  • Dance-501
Experimental: INH 208 U
single 208 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)
Drug: INH 208 U
inhaled human insulin
Other Names:
  • Dance-501
Active Comparator: LIS 18 U
single 18 U dose administration of subcutaneous insulin lispro using a 100 U/mL formulation This arm was repeated in order to evaluate intra-subject variability.
Drug: LIS 18 U
subcutaneous insulin lispro
Other Names:
  • subcutaneous insulin lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve for insulin from 0-8 hours (AUCins0-8h)
Time Frame: 0 to 8 hours following each dose
Assessment of the linearity of the dose-response curves
0 to 8 hours following each dose
Maximum concentration of insulin (CMaxIns)
Time Frame: up to 12 hours following each dose
Assessment of the linearity of the dose-response curves
up to 12 hours following each dose
Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
Time Frame: 0 to 8 hours following each dose
Assessment of the linearity of the dose-response curves
0 to 8 hours following each dose
Maximum glucose infusion rate (GIRmax)
Time Frame: up to 12 hours following each dose
Assessment of the linearity of the dose-response curves
up to 12 hours following each dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioavailability
Time Frame: 0 to 8 hours following each dose
Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to subcutaneous injected insulin lispro (LIS)
0 to 8 hours following each dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dance Biopharm Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Samba-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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