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

Dance Biopharm

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: LIS 18 U; Drug: INH 208 U; Drug: INH 69 U (high); Drug: INH 139 U; Drug: INH 69 U (low)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02716610

Samba-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

24 participants in 5 patient groups

INH 69 U (low)

Experimental group

Description:

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

Treatment:

Drug: INH 69 U (low)

INH 69 U (high)

Experimental group

Description:

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

Treatment:

Drug: INH 69 U (high)

INH 139 U

Experimental group

Description:

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.

Treatment:

Drug: INH 139 U

INH 208 U

Experimental group

Description:

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

Treatment:

Drug: INH 208 U

LIS 18 U

Active Comparator group

Description:

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.

Treatment:

Drug: LIS 18 U