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MKC253

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |MannKind Corporation|Last Updated: Jun 14, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

MKC253 · 2 trials · 2 indications

Phase 1 2
NCT00642538A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
COMPLETED20 Analytics
NCT00475371A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult MalesDiabetes Mellitus, Type 2
COMPLETED26 Analytics
PHASE1COMPLETED
A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

AUC 0-240 min post-prandial serum glucose
240 minutes
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
2 weeks

Secondary Endpoints

Incidence of pulmonary and other AEs
2 weeks
Pharmacokinetic (PK) parameters of plasma GLP-1
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
2EXPERIMENTAL1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
3EXPERIMENTAL1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
4PLACEBO_COMPARATORTIP (placebo comparison)
5ACTIVE_COMPARATOR10 ug subcutaneous control

Interventions

NameTypeDescription
MKC253 Inhalation PowderDRUGInhalation Powder, prandial
Technosphere Inhalation PowderDRUGInhalation Powder, prandial
subcutaneous injectionDRUG10µg Exenatide, prandial
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

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, w...

Countries:Netherlands
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Frequently asked questions about MKC253

What is MKC253 used for?

MKC253 is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It is administered as an inhalation powder and is currently in Phase 1 clinical development. The drug is being studied for its safety, tolerability, and pharmacological response in adults with Type 2 diabetes.

Who makes MKC253?

MKC253 is being developed by MannKind Corporation, a biopharmaceutical company traded on NASDAQ under the ticker MNKD. The company is conducting clinical trials to evaluate the safety and pharmacological response of this inhaled small molecule in patients with Type 2 Diabetes Mellitus.

What phase is MKC253 in?

MKC253 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 46 participants enrolled. The drug is investigational and has not been approved by regulatory authorities. It is being studied for the treatment of Type 2 Diabetes Mellitus.

What clinical trials has MKC253 been in?

MKC253 has been studied in two completed Phase 1 clinical trials. NCT00475371 evaluated single-dose safety and tolerability in healthy adult males, enrolling 26 participants. NCT00642538 assessed safety and pharmacological response in adults with Type 2 Diabetes Mellitus, enrolling 20 participants. Both trials were conducted in the Netherlands.

How is MKC253 administered?

MKC253 is administered as an inhalation powder. This route of delivery is being studied in clinical trials for the treatment of Type 2 Diabetes Mellitus. The drug is a small molecule and is currently in Phase 1 development, with completed trials evaluating its safety and tolerability in healthy volunteers and adults with diabetes.