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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716610
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Dance Biopharm Inc.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: INH 69 U (low) Drug: INH 69 U (high) Drug: INH 139 U Drug: INH 208 U Drug: LIS 18 U Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes
Study Start Date : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: subcutaneous insulin lispro




Primary Outcome Measures :
  1. 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

  2. Maximum concentration of insulin (CMaxIns) [ Time Frame: up to 12 hours following each dose ]
    Assessment of the linearity of the dose-response curves

  3. 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

  4. Maximum glucose infusion rate (GIRmax) [ Time Frame: up to 12 hours following each dose ]
    Assessment of the linearity of the dose-response curves


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02716610


Sponsors and Collaborators
Dance Biopharm Inc.
Investigators
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Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH

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Responsible Party: Dance Biopharm Inc.
ClinicalTrials.gov Identifier: NCT02716610    
Other Study ID Numbers: Samba-02
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs