Type 2 DiabetesPhase 2NCT00525330
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone
A Phase 2 study of Type 2 Diabetes, run by ActivX Biosciences, Inc. at 1 site in United States.
Trial summary
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2008
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years, inclusive;
- Males and females of non-childbearing potential;
- Diagnosis of type 2 diabetes mellitus according; and
- On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry
Who cannot join
- History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
- History or presence of alcoholism or drug abuse
- Typical consumption of ≥10 drinks of alcohol weekly;
- Presence of any of the following conditions:
- Significant renal impairment (glomerular filtration rate <60 mL/min [to be calculated by the central laboratory]);
- Diabetic retinopathy;
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- Diabetic gastroparesis;
- Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
- Uncontrolled high blood pressure;
- History or evidence of cardiovascular or pulmonary disease
- Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
Trial locations and contacts
1 site in 1 country.
About this study
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
- Conditions
- Type 2 Diabetes
- Being tested
- KRP-104 QD Drug: Placebo Drug: Metformin, Placebo Drug: Metformin, KRP-104 BID Drug: Placebo Drug: Metformin
- 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.
KRP-104 QD Drug: Placebo Drug: MetforminDrug
KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal
Placebo Drug: MetforminDrug
Two tablets 15 to 30 minutes before each meal, morning and evening.
KRP-104 BID Drug: Placebo Drug: MetforminDrug
KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.
| Study group | Role | What they receive |
|---|---|---|
| KRP-104 120 mg QD | Experimental | Not described Receives: Drug: KRP-104 QD Drug: Placebo Drug: Metformin |
| KRP-104 60 mg BID | Experimental | Not described Receives: Drug: KRP-104 BID Drug: Placebo Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone.
Measured: 12-weeks
Secondary outcomes (4)
To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;
Measured: 12-weeks
To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG
Measured: 12 weeks
To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-β]) in the setting of a Meal Tolerance Test(MTT)
Changes from pre-prandial to 2-hour post-prandial glucose, active GLP-1, insulin summarized by treatment group from Week 0 to Week 5 and Week 12. Percent change in 2-hour post-prandial glucose summarized by treatment group from Week 0 to Week 5 and Week 12.
Measured: 12 weeks
To assess the safety and tolerability of KRP-104;
Measured: Daily for 12 weeks to 2 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActivX Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyorin Pharmaceutical Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- David Orloff, Study chair, Medpace, Inc.Tufail Syed, Study chair, Medpace India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525330
- Sponsor's protocol ID
- 0104-003
- Status last verified
- Aug 2013
- First submitted
- 3 Sep 2007
- Last updated
- 22 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone
- ClinicalTrials.gov ID
- NCT00525330
- Acronym / sponsor ID
- 0104-003
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- ActivX Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kyorin Pharmaceutical Co.,Ltd
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Sep 2007 (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.
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KRP-104 120 mg QD | Experimental | Drug: KRP-104 QD Drug: Placebo Drug: Metformin |
| KRP-104 60 mg BID | Experimental | Drug: KRP-104 BID Drug: Placebo Drug: Metformin |
| Placebo | Placebo comparator | Drug: Placebo Drug: Metformin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 70 years, inclusive;
- Males and females of non-childbearing potential;
- Diagnosis of type 2 diabetes mellitus according; and
- On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry
Key exclusion criteria (11 listed)
- History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
- History or presence of alcoholism or drug abuse
- Typical consumption of ≥10 drinks of alcohol weekly;
- Presence of any of the following conditions:
- Uncontrolled high blood pressure;
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 |
|---|---|---|
| KRP-104 QD Drug: Placebo Drug: MetforminKRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal | Drug | KRP-104 120 mg QD |
| Placebo Drug: MetforminTwo tablets 15 to 30 minutes before each meal, morning and evening. | Drug | Placebo |
| KRP-104 BID Drug: Placebo Drug: MetforminKRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening. | Drug | KRP-104 60 mg BID |
Primary outcome
The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone.
Time frame: 12-weeks
4 secondary outcomes
To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;
Time frame: 12-weeks
To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG
Time frame: 12 weeks
To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-β]) in the setting of a Meal Tolerance Test(MTT)
Time frame: 12 weeks
To assess the safety and tolerability of KRP-104;
Time frame: Daily for 12 weeks to 2 weeks post-treatment
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 22 Aug 2013.
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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.
David Orloff study chair
Medpace, Inc.
Tufail Syed study chair
Medpace India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type 2 Diabetes, run by ActivX Biosciences, Inc. at 1 site in United States.
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 4 inclusion and 11 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 22 Aug 2013. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone. (time frame: 12-weeks). 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 22 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.