Diabetes Mellitus, Type 2Phase 1NCT00642538
A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus
A Phase 1 study testing MKC253 Inhalation Powder, Technosphere Inhalation Powder and subcutaneous injection in people with Diabetes Mellitus, Type 2, run by Mannkind Corporation at 1 site in Netherlands.
Trial summary
20 eligible subjects will be enrolled into the treatment phase of the trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MKC253 Inhalation Powder, Technosphere Inhalation Powder and subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2008to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)].
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
20 eligible subjects will be enrolled into the treatment phase of the trial.
Read the detailed description
Trial objectives are to determine the safety \& pharmacological response of MKC253 Inhalation Powder.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- MKC253 Inhalation Powder, Technosphere Inhalation Powder, subcutaneous injection
- Keywords
- Diabetic adult male, diabetic postmenopausal women
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKC253 Inhalation PowderDrug
Inhalation Powder, prandial
Technosphere Inhalation PowderDrug
Inhalation Powder, prandial
subcutaneous injectionDrug
10µg Exenatide, prandial
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder Receives: Drug: MKC253 Inhalation Powder |
| 2 | Experimental | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder Receives: Drug: MKC253 Inhalation Powder |
| 3 | Experimental | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder Receives: Drug: MKC253 Inhalation Powder |
| 4 | Placebo comparator | TIP (placebo comparison) Receives: Drug: Technosphere Inhalation Powder |
| 5 | Active comparator | 10 ug subcutaneous control Receives: Drug: subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-240 min post-prandial serum glucose
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Boss, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642538
- Sponsor's protocol ID
- MKC-253-002
- Other IDs
- EudraCT #: 2007-003430-42
- Status last verified
- Jun 2012
- First submitted
- 3 Mar 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00642538
- Acronym / sponsor ID
- MKC-253-002
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetic adult male, diabetic postmenopausal women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MKC253 Inhalation Powder1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 2 | Experimental | Drug: MKC253 Inhalation Powder1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 3 | Experimental | Drug: MKC253 Inhalation Powder1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 4 | Placebo comparator | Drug: Technosphere Inhalation PowderTIP (placebo comparison) |
| 5 | Active comparator | Drug: subcutaneous injection10 ug subcutaneous control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MKC253 Inhalation PowderInhalation Powder, prandial | Drug | 1, 2, 3 |
| Technosphere Inhalation PowderInhalation Powder, prandial | Drug | 4 |
| subcutaneous injection10µg Exenatide, prandial | Drug | 5 |
Primary outcome
AUC 0-240 min post-prandial serum glucose
Time frame: 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Boss study director
Mannkind Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MKC253 Inhalation Powder, Technosphere Inhalation Powder and subcutaneous injection in people with Diabetes Mellitus, Type 2, run by Mannkind Corporation at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0-240 min post-prandial serum glucose (time frame: 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.