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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: MKC253 Inhalation Powder; Drug: Technosphere Inhalation Powder; Drug: subcutaneous injection

• Registration Number: NCT00642538
• Lead Sponsor: Mannkind Corporation

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-25
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	MKC253 Inhalation Powder	1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
2	MKC253 Inhalation Powder	1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
3	MKC253 Inhalation Powder	1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
4	Technosphere Inhalation Powder	TIP (placebo comparison)
5	subcutaneous injection	10 ug subcutaneous control

Primary Outcome Measures

Name	Time	Method
AUC 0-240 min post-prandial serum glucose	240 minutes

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Zuidlaren, Netherlands