Diabetes MellitusPhase 3NCT00655863
Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
A Phase 3 study testing Alogliptin and Pioglitazone and Alogliptin in people with Diabetes Mellitus, run by Takeda at 2 sites in 2 countries.
Trial summary
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Alogliptin and Pioglitazone and Alogliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of type 2 diabetes
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
- Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
- Fasting plasma glucose less than 13.3 mmol per L.
- Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
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- Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
- Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
- If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
- Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.
Who cannot join
- History of type 1 diabetes.
- History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
- Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
- History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
- Hemoglobin less than 120 g per L for males and less than100 g per L for females.
- Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
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- Serum creatinine level greater than 133 μmol per L.
- Fasting total cholesterol greater than 6.5 mmol per L.
- New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- History of acute metabolic diabetic complications.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with human immunodeficiency virus.
- History of diabetic gastro paresis.
- History of gastric bypass surgery.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
Read the detailed description
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.
Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.
This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.
- Conditions
- Diabetes Mellitus
- Being tested
- Alogliptin and Pioglitazone, Alogliptin, Placebo
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic; Dyslipidemia, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alogliptin and PioglitazoneDrug
Also called alogliptin, SYR110322, Actos, AD-4833
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
AlogliptinDrug
Also called SYR110322, SYR-322
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
PlaceboDrug
Also called Actos, AD-4833, SYR-322
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo QD | Placebo comparator | Not described Receives: Drug: Placebo |
| Alogliptin 25 mg QD | Experimental | Not described Receives: Drug: Alogliptin |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Experimental | Not described Receives: Drug: Alogliptin and Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Measured: Baseline and Week 16.
Secondary outcomes (17)
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.
Measured: Baseline and Week 4.
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
Postprandial changes over time at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucose
Postprandial changes over time at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Insulin
Postprandial changes over time at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon
Postprandial changes over time at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Glycosylated Hemoglobin
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.
Measured: Baseline, Week 8 and Week 16.
Change From Baseline in Fasting Plasma Glucose
The change in fasting plasma glucose collected at each week indicated relative to baseline.
Measured: Baseline, Week 4, Week 8 and Week 16.
Change From Baseline in Postprandial C-Peptide
The change in postprandial C-peptide collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Proinsulin
The change in postprandial proinsulin collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
The change in hs-CRP collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Adiponectin
The change in adiponectin collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
The change in VCAM collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
The change in ICAM collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in e-Selectin
The change in e-Selectin collected at each week indicated relative to baseline.
Measured: Baseline, Week 4 and Week 16.
Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.
Measured: Baseline and Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655863
- Sponsor's protocol ID
- SYR-322_301
- Other IDs
- 2007-000486-38, U1111-1113-2081, NL22649.029.08
- Status last verified
- May 2013
- First submitted
- 4 Apr 2008
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eliasson B, Moller-Goede D, Eeg-Olofsson K, Wilson C, Cederholm J, Fleck P, Diamant M, Taskinen MR, Smith U. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia. 2012 Apr;55(4):915-25. doi: 10.1007/s00125-011-2447-3. Epub 2012 Jan 12.
PubMed 22237690
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00655863
- Acronym / sponsor ID
- SYR-322_301
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic; Dyslipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 27 May 2013
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 compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
Detailed description
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.
Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.
This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo QD | Placebo comparator | Drug: Placebo |
| Alogliptin 25 mg QD | Experimental | Drug: Alogliptin |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Experimental | Drug: Alogliptin and Pioglitazone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of type 2 diabetes
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
- Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
- Fasting plasma glucose less than 13.3 mmol per L.
Key exclusion criteria (15 listed)
- History of type 1 diabetes.
- History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
- Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
- History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
- Hemoglobin less than 120 g per L for males and less than100 g per L for females.
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 |
|---|---|---|
| Alogliptin and PioglitazoneAlso: alogliptin, SYR110322, Actos, AD-4833Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. | Drug | Alogliptin 25 mg QD + Pioglitazone 30 mg QD |
| AlogliptinAlso: SYR110322, SYR-322Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. | Drug | Alogliptin 25 mg QD |
| PlaceboAlso: Actos, AD-4833, SYR-322Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. | Drug | Placebo QD |
Primary outcome
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
Time frame: Baseline and Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
17 secondary outcomes
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
Time frame: Baseline and Week 4.
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
Time frame: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
Time frame: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucose
Time frame: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Insulin
Time frame: Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Glycosylated Hemoglobin
Time frame: Baseline, Week 8 and Week 16.
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline, Week 4, Week 8 and Week 16.
Change From Baseline in Postprandial C-Peptide
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Proinsulin
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Adiponectin
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in e-Selectin
Time frame: Baseline, Week 4 and Week 16.
Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
Time frame: Baseline and Week 16.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22237690Eliasson B, Moller-Goede D, Eeg-Olofsson K, Wilson C, Cederholm J, Fleck P, Diamant M, Taskinen MR, Smith U. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia. 2012 Apr;55(4):915-25. doi: 10.1007/s00125-011-2447-3. Epub 2012 Jan 12.
- ACTOS Package Insert.Link provided by the sponsor.
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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.
Medical Director study director
Takeda
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alogliptin and Pioglitazone and Alogliptin in people with Diabetes Mellitus, run by Takeda at 2 sites in 2 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 10 inclusion and 15 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. 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?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. (time frame: Baseline and Week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655863, which also lists 1 linked publication.
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 27 May 2013.