Type 2 Diabetes MellitusPhase 1NCT02713477
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 and Insulin glargine HOE901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). 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?
- Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 and Insulin glargine HOE901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2016to Jun 2016
- Phase
- Phase 1
- 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
- Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.
- Patients aged 20 to 75 years at screening.
- Body mass index ≤35 kg/m^2 at screening.
- Glycohemoglobin ≥7.0% and ≤10.0% at screening.
- Fasting C-peptide ≥0.6 ng/mL at screening.
Who cannot join
- Diabetes other than T2DM.
- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
- History of hypoglycemia unawareness.
- Hemoglobinopathy or hemolytic anemia.
- History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
Show all 10Show fewer
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment.
- Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
- If female, pregnancy or breast-feeding.
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Primary Objective:
To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).
Read more
Secondary Objectives:
- To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
- To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM.
- To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
Read the detailed description
The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010, Insulin glargine HOE901, Placebo
- 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.
Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin glargine HOE901Drug
Also called Lantus
Pharmaceutical form: solution
Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine/ lixisenatide dose 1 Test 1 | Experimental | Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition Receives: Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 |
| Insulin glargine/ lixisenatide dose 2 Test 2 | Experimental | Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition Receives: Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 |
| Placebo - Reference 1 | Placebo comparator | Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition Receives: Drug: Placebo |
| Insulin glargine (Lantus) - Reference 2 | Other | Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition Receives: Drug: Insulin glargine HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of plasma glucose concentrations
Measured: 1 day (D1) in each treatment period
Secondary outcomes (8)
Measurement of serum insulin concentrations
Measured: 1 day (D1) in each treatment period
Measurement of serum C-peptide concentrations
Measured: 1 day (D1) in each treatment period
Measurement of plasma glucagon concentrations
Measured: 1 day (D1) in each treatment period
Measurement of plasma lixisenatide concentrations
Measured: 1 day (D1) in each treatment period
Number of patients with hypoglycemic events
Measured: Up to 2 weeks after each treatment
Number of patients with adverse events
Measured: Up to 2 weeks after each treatment
Measurement of anti-lixisenatide antibodies
Measured: 2 days (prior to first dosing and end of study visit)
Measurement of anti-insulin antibodies
Measured: 2 days (prior to first dosing and end of study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02713477
- Sponsor's protocol ID
- PDY14115
- Other IDs
- U1111-1176-6235
- Status last verified
- Jun 2016
- First submitted
- 15 Mar 2016
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Inoue M, Lorenz M, Muto H, Wesch R, Hashimoto Y. Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):2001-2005. doi: 10.1111/dom.13757. Epub 2019 May 24.
PubMed 31050109
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02713477
- Acronym / sponsor ID
- PDY14115
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Mar 2016 (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 assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).
Secondary Objectives:
- To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
- To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM.
- To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
Detailed description
The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine/ lixisenatide dose 1 Test 1 | Experimental | Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition |
| Insulin glargine/ lixisenatide dose 2 Test 2 | Experimental | Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition |
| Placebo - Reference 1 | Placebo comparator | Drug: PlaceboReference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition |
| Insulin glargine (Lantus) - Reference 2 | Other | Drug: Insulin glargine HOE901Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.
- Patients aged 20 to 75 years at screening.
- Body mass index ≤35 kg/m^2 at screening.
- Glycohemoglobin ≥7.0% and ≤10.0% at screening.
- Fasting C-peptide ≥0.6 ng/mL at screening.
Key exclusion criteria (10 listed)
- Diabetes other than T2DM.
- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
- History of hypoglycemia unawareness.
- Hemoglobinopathy or hemolytic anemia.
- History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.
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 |
|---|---|---|
| Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Insulin glargine/ lixisenatide dose 1 Test 1, Insulin glargine/ lixisenatide dose 2 Test 2 |
| Insulin glargine HOE901Also: LantusPharmaceutical form: solution Route of administration: subcutaneous | Drug | Insulin glargine (Lantus) - Reference 2 |
| PlaceboPharmaceutical form: solution Route of administration: subcutaneous | Drug | Placebo - Reference 1 |
Primary outcome
Measurement of plasma glucose concentrations
Time frame: 1 day (D1) in each treatment period
8 secondary outcomes
Measurement of serum insulin concentrations
Time frame: 1 day (D1) in each treatment period
Measurement of serum C-peptide concentrations
Time frame: 1 day (D1) in each treatment period
Measurement of plasma glucagon concentrations
Time frame: 1 day (D1) in each treatment period
Measurement of plasma lixisenatide concentrations
Time frame: 1 day (D1) in each treatment period
Number of patients with hypoglycemic events
Time frame: Up to 2 weeks after each treatment
Number of patients with adverse events
Time frame: Up to 2 weeks after each treatment
Measurement of anti-lixisenatide antibodies
Time frame: 2 days (prior to first dosing and end of study visit)
Measurement of anti-insulin antibodies
Time frame: 2 days (prior to first dosing and end of study visit)
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 16 Jun 2020.
- Results publication: PubMed 31050109Inoue M, Lorenz M, Muto H, Wesch R, Hashimoto Y. Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):2001-2005. doi: 10.1111/dom.13757. Epub 2019 May 24.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 and Insulin glargine HOE901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site 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 5 inclusion and 10 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 16 Jun 2020. 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measurement of plasma glucose concentrations (time frame: 1 day (D1) in each treatment period). 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 NCT02713477, 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 16 Jun 2020.