Type 2 Diabetes MellitusPhase 4NCT02200991
Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
A Phase 4 study testing LIXISENATIDE AVE0010, Sitagliptin and Insulin glargine HOE901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 20 sites in Japan.
Trial summary
Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate: Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LIXISENATIDE AVE0010, Sitagliptin and Insulin glargine HOE901
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 20 sitesJapan
- Study dates
- Aug 2014to Nov 2015
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis
- Aged 20-75 years
- Hemoglobin A1C ≥7.0%-≤10.0%
- Fasting plasma glucose ≤180 mg/dL at screening
- Stable treatment (±20%) with Lantus for 3 months or more prior to screening.
- Sulfonylurea dose stable for 3 months or more prior to screening
Who cannot join
- Type 1 diabetes mellitus
- Pregnancy or lactation
- Hypersensitivity to Lixisenatide
- Severely uncontrolled glycemic situation
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
- History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
Show all 11Show fewer
- History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
- Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg
- Amylase and/or lipase >3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) >2 times the upper limit of the normal laboratory range
- End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Investigational Site Number 392-107
Atsugi-shi
Investigational Site Number 392-125
Chiyoda-ku
Investigational Site Number 392-121
Chuoh-ku
Investigational Site Number 392-102
Ichihara-shi
Investigational Site Number 392-103
Kawaguchi-shi
Investigational Site Number 392-114
Kitamoto-shi
Investigational Site Number 392-122
Kobe
Investigational Site Number 392-126
Kumamoto
Investigational Site Number 392-127
Kumamoto
Investigational Site Number 392-101
Kyoto
Investigational Site Number 392-106
Matsudo-shi
Investigational Site Number 392-124
Mitaka-shi
Investigational Site Number 392-108
Mito
Investigational Site Number 392-119
Nerima-ku
Investigational Site Number 392-117
Okayama
Investigational Site Number 392-111
Sagamihara-shi
Investigational Site Number 392-110
Sapporo
Investigational Site Number 392-116
Satsumasendai-shi
Investigational Site Number 392-105
Shizuoka
Investigational Site Number 392-118
Suita-shi
About this study
Official title: A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus
Primary Objective:
To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29.
Secondary Objectives:
To demonstrate:
- Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast
- Delaying gastric emptying (13C-acetic acid breath test)
- Safety and tolerability
Read the detailed description
The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances.
13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LIXISENATIDE AVE0010, Sitagliptin, Insulin glargine HOE901
- 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.
LIXISENATIDE AVE0010Drug
Pharmaceutical form:solution Route of administration: subcutaneous
SitagliptinDrug
Also called Januvia
Pharmaceutical form:tablet Route of administration: oral
Insulin glargine HOE901Drug
Also called Lantus
Pharmaceutical form:solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Lixisenatide | Experimental | Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks.
Lantus solostar as base treatment: Subcutaneous injection in the abdomen. Receives: Drug: LIXISENATIDE AVE0010; Drug: Insulin glargine HOE901 |
| Sitagliptin - Januvia | Active comparator | 50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks.
Lantus solostar as base treatment: Subcutaneous injection in the abdomen. Receives: Drug: Sitagliptin; Drug: Insulin glargine HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
Measured: Day 29 after first intake of investigational product
Secondary outcomes (5)
Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
Measured: Day 29 after first intake of investigational product
Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
Measured: Day 29 after first intake of investigational product
Change from baseline in glucagon levels at Day 29 after a standardized breakfast
Measured: Day 29 after first intake of investigational product
Change in gastric emptying half life (13C-acetic acid breath test)
Measured: Day 29 after first intake of investigational product
Proportion of patients with adverse events
Measured: Up to Day 33 from the first intake of investigational medicinal product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200991
- Sponsor's protocol ID
- LIXISL06651
- Other IDs
- U1111-1159-5323
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017 Sep;19(9):1252-1259. doi: 10.1111/dom.12945. Epub 2017 Apr 27.
PubMed 28345162
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02200991
- Acronym / sponsor ID
- LIXISL06651
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jul 2014 (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.
Primary Objective:
To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29.
Secondary Objectives:
To demonstrate:
- Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast
- Delaying gastric emptying (13C-acetic acid breath test)
- Safety and tolerability
Detailed description
The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances.
13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lixisenatide | Experimental | Drug: LIXISENATIDE AVE0010, Drug: Insulin glargine HOE901Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen. |
| Sitagliptin - Januvia | Active comparator | Drug: Sitagliptin, Drug: Insulin glargine HOE90150 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis
- Aged 20-75 years
- Hemoglobin A1C ≥7.0%-≤10.0%
- Fasting plasma glucose ≤180 mg/dL at screening
- Stable treatment (±20%) with Lantus for 3 months or more prior to screening.
Key exclusion criteria (11 listed)
- Type 1 diabetes mellitus
- Pregnancy or lactation
- Hypersensitivity to Lixisenatide
- Severely uncontrolled glycemic situation
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
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 |
|---|---|---|
| LIXISENATIDE AVE0010Pharmaceutical form:solution Route of administration: subcutaneous | Drug | Lixisenatide |
| SitagliptinAlso: JanuviaPharmaceutical form:tablet Route of administration: oral | Drug | Sitagliptin - Januvia |
| Insulin glargine HOE901Also: LantusPharmaceutical form:solution Route of administration: subcutaneous | Drug | Lixisenatide, Sitagliptin - Januvia |
Primary outcome
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
5 secondary outcomes
Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change from baseline in glucagon levels at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change in gastric emptying half life (13C-acetic acid breath test)
Time frame: Day 29 after first intake of investigational product
Proportion of patients with adverse events
Time frame: Up to Day 33 from the first intake of investigational medicinal product
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 5 Oct 2016.
- Derived from this study: PubMed 28345162Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017 Sep;19(9):1252-1259. doi: 10.1111/dom.12945. Epub 2017 Apr 27.
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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.
Clinical Sciences & Operations study director
Sanofi
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LIXISENATIDE AVE0010, Sitagliptin and Insulin glargine HOE901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 20 sites in Japan.
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 6 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 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast (time frame: Day 29 after first intake of investigational product). 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 NCT02200991, 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 5 Oct 2016.