Type 2 Diabetes MellitusPhase 3NCT00958269
Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
A Phase 3 study testing dutogliptin and sitagliptin in people with Type 2 Diabetes Mellitus and Renal Impairment, run by Phenomix at 43 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Renal Impairment
- What is being tested?
- dutogliptin and sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 43 sitesin 3 countries
- Study dates
- Aug 2009to Nov 2011
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Renal impairment (moderate and severe)
- Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
- HbA1c 7.0% - 10.5%, inclusive
- Male or female subjects between the ages of 18 and 85 years, inclusive.
Who cannot join
- Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
- Kidney transplant
Trial locations and contacts
43 sites in 3 countries.
43 sites in 3 countries
United States23 sites
Phenomix Investigational Site 113
Alexandria, Virginia
Phenomix Investigational Site 101
Augusta, Georgia
Phenomix Investigational Site 102
Baton Rouge, Louisiana
Phenomix Investigational Site 107
Columbia, South Carolina
Phenomix Investigational Site 103
Fort Worth, Texas
Phenomix Investigational Site 117
Honolulu, Hawaii
Phenomix Investigational Site 106
Houston, Texas
Phenomix Investigational Site 112
Lauderdale Lakes, Florida
Phenomix Investigational Site 121
Long Beach, California
Phenomix Investigational Site 110
Lynwood, California
Phenomix Investigational Site 118
Lynwood, California
Phenomix Investigational Site 111
Nashville, Tennessee
Phenomix Investigational Site 104
Ocala, Florida
Phenomix Investigational Site 119
Orange, California
Phenomix Investigational Site 109
Palm Springs, California
Phenomix Investigational Site 116
Pembroke Pines, Florida
Phenomix Investigational Site 100
Rockville, Maryland
Phenomix Investigational Site 125
Rockville, Maryland
Phenomix Investigational Site 108
San Antonio, Texas
Phenomix Investigational Site 114
Springfield Gardens, New York
Phenomix Investigational Site 115
Tempe, Arizona
Phenomix Investigational Site 122
Whittier, California
Phenomix Investigational Site 120
Winston-Salem, North Carolina
Russia13 sites
Phenomix Investigational Site 208
Kemerovo
Phenomix Investigational Site 203
Moscow
Phenomix Investigational Site 204
Moscow
Phenomix Investigational Site 209
Moscow
Phenomix Investigational Site 211
Moscow
Phenomix Investigational Site 205
Novosibirsk
Phenomix Investigational Site 207
Perm
Phenomix Investigational Site 206
Petrozavodsk
Phenomix Investigational Site 200
Saint Petersburg
Phenomix Investigational Site 201
Saint Petersburg
Phenomix Investigational Site 210
Saint Petersburg
Phenomix Investigational Site 212
Saint Petersburg
Phenomix Investigational Site 213
Saint Petersburg
Ukraine7 sites
Phenomix Investigational Site 304
Chernivtsi
Phenomix Investigational Site 300
Kyiv
Phenomix Investigational Site 301
Kyiv
Phenomix Investigational Site 306
Kyiv
Phenomix Investigational Site 302
Odesa
Phenomix Investigational Site 303
Vinnytsa
Phenomix Investigational Site 307
Zaporizhzhya
About this study
Official title: A Randomized, Double-Blind, Placebo- and Sitagliptin-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment Including Subjects on Hemodialysis
The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.
- Conditions
- Type 2 Diabetes Mellitus, Renal Impairment
- Being tested
- dutogliptin, placebo, sitagliptin
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin, PHX1149
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutogliptinDrug
100 mg QD
dutogliptinDrug
200 mg QD
placeboDrug
sitagliptinDrug
25 mg QD
sitagliptinDrug
50 mg QD
| Study group | Role | What they receive |
|---|---|---|
| dutogliptin (double-blind, placebo-controlled period) | Experimental | weeks 1-26 Receives: Drug: dutogliptin |
| dutogliptin (single-blind, active-controlled period) | Experimental | weeks 27-52 Receives: Drug: dutogliptin |
| placebo (double-blind, placebo-controlled period) | Placebo comparator | weeks 1-26 Receives: Drug: placebo |
| placebo (single-blind, active-controlled period) | Placebo comparator | weeks 27-52 Receives: Drug: placebo |
| sitagliptin (single-blind, active-controlled period) | Active comparator | weeks 27-52 Receives: Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs
Measured: Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study)
Secondary outcomes (4)
Change of HbA1c
Measured: Day 1 to Day 182
Change of fasting plasma glucose
Measured: Day 1 to Day 182
Plasma dutogliptin levels
Measured: Days 1, 198 and 182
Per cent ex vivo DPP4 inhibition after drug dosing
Measured: Days 1, 98, and 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011 (estimated)
- Study completionNov 2011 (estimated)
Why it stopped: Technical/operational issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958269
- Sponsor's protocol ID
- PHX1149-PROT306
- Status last verified
- Feb 2010
- First submitted
- 12 Aug 2009
- Last updated
- 3 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Sitagliptin-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment Including Subjects on Hemodialysis
- ClinicalTrials.gov ID
- NCT00958269
- Acronym / sponsor ID
- PHX1149-PROT306
- Conditions
- Type 2 Diabetes Mellitus, Renal Impairment
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin, PHX1149
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical/operational issues
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- PhenomixIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 13 Aug 2009 (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.
The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dutogliptin (double-blind, placebo-controlled period) | Experimental | Drug: dutogliptinweeks 1-26 |
| dutogliptin (single-blind, active-controlled period) | Experimental | Drug: dutogliptinweeks 27-52 |
| placebo (double-blind, placebo-controlled period) | Placebo comparator | Drug: placeboweeks 1-26 |
| placebo (single-blind, active-controlled period) | Placebo comparator | Drug: placeboweeks 27-52 |
| sitagliptin (single-blind, active-controlled period) | Active comparator | Drug: sitagliptinweeks 27-52 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus
- Renal impairment (moderate and severe)
- Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
- HbA1c 7.0% - 10.5%, inclusive
- Male or female subjects between the ages of 18 and 85 years, inclusive.
Key exclusion criteria (2 listed)
- Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
- Kidney transplant
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 |
|---|---|---|
| dutogliptin100 mg QD | Drug | dutogliptin (double-blind, placebo-controlled period), dutogliptin (single-blind, active-controlled period) |
| dutogliptin200 mg QD | Drug | dutogliptin (double-blind, placebo-controlled period), dutogliptin (single-blind, active-controlled period) |
| placebo | Drug | placebo (double-blind, placebo-controlled period), placebo (single-blind, active-controlled period) |
| sitagliptin25 mg QD | Drug | sitagliptin (single-blind, active-controlled period) |
| sitagliptin50 mg QD | Drug | sitagliptin (single-blind, active-controlled period) |
Primary outcome
Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs
Time frame: Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study)
4 secondary outcomes
Change of HbA1c
Time frame: Day 1 to Day 182
Change of fasting plasma glucose
Time frame: Day 1 to Day 182
Plasma dutogliptin levels
Time frame: Days 1, 198 and 182
Per cent ex vivo DPP4 inhibition after drug dosing
Time frame: Days 1, 98, and 182
Results and safety
The study was stopped early (reason given: Technical/operational issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dutogliptin and sitagliptin in people with Type 2 Diabetes Mellitus and Renal Impairment, run by Phenomix at 43 sites in 3 countries.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Russia, Ukraine. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Technical/operational issues). Results are not available in the source record.
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?
Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs (time frame: Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study)). 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 3 Feb 2010.