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

NCT00642538 | Completed Phase 1

• 2 other identifiers: MKC-253-002EudraCT #: 2007-003430-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetic adult male, diabetic postmenopausal women

Outcome Measures

Primary Outcomes (1)

• AUC 0-240 min post-prandial serum glucose

  240 minutes

Study Arms (5)

1

EXPERIMENTAL

1.5 mg dose of GLP-1 as MKC253 Inhalation Powder

Drug: MKC253 Inhalation Powder

2

EXPERIMENTAL

1.5 mg dose of GLP-1 as MKC253 Inhalation Powder

Drug: MKC253 Inhalation Powder

3

EXPERIMENTAL

1.5 mg dose of GLP-1 as MKC253 Inhalation Powder

Drug: MKC253 Inhalation Powder

4

PLACEBO COMPARATOR

TIP (placebo comparison)

Drug: Technosphere Inhalation Powder

5

ACTIVE COMPARATOR

10 ug subcutaneous control

Drug: subcutaneous injection

Interventions

MKC253 Inhalation Powder DRUG

Inhalation Powder, prandial

1; 2; 3

Technosphere Inhalation Powder DRUG

Inhalation Powder, prandial

4

subcutaneous injection DRUG

10µg Exenatide, prandial

5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[ie, thiazolidinediones (TZDs), dipeptyl peptidase inhibitors (DPP-IV), Symlin (pramlintide acetate) and or Byetta (exenatide)\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

University Medical Centre Groningen

Zuidlaren, 9470 AE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Anders Boss

  Mannkind Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 25, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

NL (1)