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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: MKC253 Inhalation Powder; Drug: Technosphere Inhalation Powder; Drug: subcutaneous injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands, 9470 AE
    • University Medical Centre Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder	Drug: MKC253 Inhalation Powder; Inhalation Powder, prandial
Experimental: 2; 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder	Drug: MKC253 Inhalation Powder; Inhalation Powder, prandial
Experimental: 3; 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder	Drug: MKC253 Inhalation Powder; Inhalation Powder, prandial
Placebo Comparator: 4; TIP (placebo comparison)	Drug: Technosphere Inhalation Powder; Inhalation Powder, prandial
Active Comparator: 5; 10 ug subcutaneous control	Drug: subcutaneous injection; 10µg Exenatide, prandial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC 0-240 min post-prandial serum glucose	240 minutes

Collaborators and Investigators

• Sponsor: Mannkind Corporation
• Investigators: Study Director: Anders Boss, Mannkind Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: March 3, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Diabetic adult male, diabetic postmenopausal women
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MKC-253-002; EudraCT #: 2007-003430-42