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

Study Overview
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Brief Summary
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20 eligible subjects will be enrolled into the treatment phase of the trial.

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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: MKC253 Inhalation Powder
* Drug: Technosphere Inhalation Powder
* Drug: subcutaneous injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic adult male, diabetic postmenopausal women