Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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INH 69 U (low)

single 69 U dose administration of Dance inhaled human insulin using a low-concentration formulation (300 U/mL)

Group Type EXPERIMENTAL

INH 69 U (low)

Intervention Type DRUG

inhaled human insulin

INH 69 U (high)

single 69 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)

Group Type EXPERIMENTAL

INH 69 U (high)

Intervention Type DRUG

inhaled human insulin

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.

Group Type EXPERIMENTAL

INH 139 U

Intervention Type DRUG

inhaled human insulin

INH 208 U

single 208 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)

Group Type EXPERIMENTAL

INH 208 U

Intervention Type DRUG

inhaled human insulin

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.

Group Type ACTIVE_COMPARATOR

LIS 18 U

Intervention Type DRUG

subcutaneous insulin lispro

Interventions

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INH 69 U (low)

inhaled human insulin

Intervention Type DRUG

INH 69 U (high)

inhaled human insulin

Intervention Type DRUG

INH 139 U

inhaled human insulin

Intervention Type DRUG

INH 208 U

inhaled human insulin

Intervention Type DRUG

LIS 18 U

subcutaneous insulin lispro

Intervention Type DRUG

Other Intervention Names

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Dance-501 Dance-501 Dance-501 Dance-501 subcutaneous insulin lispro

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No