A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 1, Repeated Single-Dose, Double Blind, Randomized, Five Treatment Controlled Safety and Pharmacological Response Evaluation Trial of MKC253 Inhalation Powder in Adult Male and Postmenopausal Female Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642538
• Other study ID #: MKC-253-002
• Secondary ID: EudraCT #: 2007-
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2008
• Last updated: June 12, 2012
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: June 2012
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

20 eligible subjects will be enrolled into the treatment phase of the trial.

Description:

Trial objectives are to determine the safety & pharmacological response of MKC253 Inhalation Powder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Non-smoking males and females between 18 and 70 years of age

• Body Mass Index (BMI) of < 32 kg/m2

• Diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. For subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label.

• HbA1c = 6.2 to = 8.5%. Fasting C-peptide = 0.5 ng/mL. On the last 3 days of the washout period (Day -3, -2, and -1) subjects should have a FBG (finger stick) = 13.5 mmol/L.

• Normal pulmonary function and performance on pulmonary function tests

• Written Informed Consent

• Treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks [ie, thiazolidinediones (TZDs), dipeptyl peptidase inhibitors (DPP-IV), Symlin (pramlintide acetate) and or Byetta (exenatide)].

Exclusion Criteria:

• Exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.

• Use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the PI and Sponsor. The use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study.

• Significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC OR FEV1).

• Serum creatinine above Upper Limit of Normal (ULN) as defined by the laboratory

• Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• MKC253 Inhalation Powder
Inhalation Powder, prandial
• Technosphere Inhalation Powder
Inhalation Powder, prandial
• subcutaneous injection
10µg Exenatide, prandial

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0-240 min post-prandial serum glucose		240 minutes	No