Clinical trial NCT00642538: A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetic adult male, diabetic postmenopausal women
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC 0-240 min post-prandial serum glucose
timeFrame: 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: Mannkind Corporation
name: Anders Boss
role: STUDY_DIRECTOR
References: