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A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus
This study has been completed.
First Received: March 3, 2008   Last Updated: September 22, 2008   History of Changes
Sponsored by: Mannkind Corporation
Information provided by: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00642538
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: MKC253 Inhalation Powder
Drug: Technosphere Inhalation Powder
Drug: subcutaneous injection
Phase I

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • AUC 0-240 min post-prandial serum glucose [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
Drug: MKC253 Inhalation Powder
Inhalation Powder, prandial
2: Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
Drug: MKC253 Inhalation Powder
Inhalation Powder, prandial
3: Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
Drug: MKC253 Inhalation Powder
Inhalation Powder, prandial
4: Placebo Comparator
TIP (placebo comparison)
Drug: Technosphere Inhalation Powder
Inhalation Powder, prandial
5: Active Comparator
10 ug subcutaneous control
Drug: subcutaneous injection
10µg Exenatide, prandial

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642538

Locations
Netherlands
University Medical Centre Groningen
Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Anders Boss Mannkind Corporation
  More Information

No publications provided

Responsible Party: MannKind Corporation ( Cheif Medical Officer )
Study ID Numbers: MKC-253-002, EudraCT #: 2007-003430-42
Study First Received: March 3, 2008
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00642538     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Mannkind Corporation:
Diabetic adult male, diabetic postmenopausal women

Study placed in the following topic categories:
Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009