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Type 2 Diabetes MellitusPhase 4NCT02545842

Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

A Phase 4 study testing INSULIN GLARGINE in people with Type 2 Diabetes Mellitus, run by Sanofi at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) < 7%. Secondary Objectives: The control rate of HbA1c ≤6.5% achievement. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
INSULIN GLARGINE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
947 participants
Where
44 sitesChina
Study dates
7 Sep 2015to 20 Apr 2018
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 65 years old.
  • Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months:
  • If on 1 OAD, provided with the following doses (including but not limited to):
  • α-glucosidase inhibitor: 100mg, three times a day (tid);
  • metformin: 1.5-2.0 g/day;
  • sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose;
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  • thiazolidinediones: eg. pioglitazone, 30-40 mg/day.
  • Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert.
  • If on 2-3 OADs, any range of dose is acceptable.
  • HbA1c >7%, and ≤10.5%.
  • FPG >7 mmol/L.
  • Body mass index (BMI) ≥20 kg/m^2, and ≤40 kg/m^2.
  • Diabetes duration ≥1 year.
  • Physician decides to and the patient is willing to start basal insulin (BI) treatment.
  • Willing to join the study and sign the informed consent.

Who cannot join

  • Type 1 diabetes patients.
  • Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months).
  • Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening.
  • Known hypoglycemia unawareness or recurrent hypoglycemia.
  • Hypersensitivity to study drug or its excipients.
  • Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up.
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  • Pregnancy or breastfeeding women.
  • Have any mental disorders, lack self-control or not able to express accurately.
  • Involved in another clinical trial simultaneously or within a 1 month before start of trial.
  • 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

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Investigational Site Number 156053

    Anshan

  • Investigational Site Number 156001

    Beijing

  • Investigational Site Number 156002

    Beijing

  • Investigational Site Number 156006

    Beijing

  • Investigational Site Number 156013

    Changchun, 130033

  • Investigational Site Number 156014

    Changchun, 130033

  • Investigational Site Number 156022

    Changde, 415000

  • Investigational Site Number 156017

    Changsha

  • Investigational Site Number 156034

    Changzhou

  • Investigational Site Number 156023

    Chenzhou

  • Investigational Site Number 156026

    Guangzhou, 510515

  • Investigational Site Number 156029

    Haikou, 570102

  • Investigational Site Number 156028

    Haikou

  • Investigational Site Number 156040

    Haikou

  • Investigational Site Number 156039

    Hangzhou, 310013

  • Investigational Site Number 156038

    Hangzhou

  • Investigational Site Number 156042

    Hangzhou

  • Investigational Site Number 156044

    Hangzhou

  • Investigational Site Number 156048

    Hefei

  • Investigational Site Number 156050

    Hefei

  • Investigational Site Number 156011

    Kunming

  • Investigational Site Number 156052

    Kunming

  • Investigational Site Number 156016

    Lanzhou

  • Investigational Site Number 156041

    Lishui

  • Investigational Site Number 156020

    Nanchang, 330006

  • Investigational Site Number 156018

    Nanchang

  • Investigational Site Number 156019

    Nanchang

  • Investigational Site Number 156031

    Nanjing

  • Investigational Site Number 156043

    Nanjing

  • Investigational Site Number 156049

    Nanjing

  • Investigational Site Number 156035

    Shanghai

  • Investigational Site Number 156036

    Shanghai

  • Investigational Site Number 156047

    Shanghai

  • Investigational Site Number 156027

    Shantou

  • Investigational Site Number 156015

    Shenyang

  • Investigational Site Number 156054

    Shijiazhuang

  • Investigational Site Number 156007

    Tangshan, 063000

  • Investigational Site Number 156010

    Tianjin, 300032

  • Investigational Site Number 156055

    Wuhan, 430000

  • Investigational Site Number 156037

    Xuzhou

  • Investigational Site Number 156033

    Yangzhou

  • Investigational Site Number 156030

    Yueyang

  • Investigational Site Number 156032

    Zhenjiang, 212001

  • Investigational Site Number 156025

    Zhuzhou, 412000

Other trials in China

About this study

Official title: Titration Target for Chinese Type 2 Diabetes Mellitus Patients Using Insulin Glargine to Achieve Glycaemic Goals: An Assessment of Three Different Fasting Plasma Glucose Targets - BEYOND III/FPG GOAL Study

Primary Objective:

To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) < 7%.

Secondary Objectives:

The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10 mmol/L).

Read the detailed description

The study duration for each patient will be 27 weeks.

Being tested
INSULIN GLARGINE
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 GLARGINEDrug

    Also called HOE901

    Pharmaceutical form: solution

    Route of administration: subcutaneous

Study groups in NCT02545842
Study groupRoleWhat they receive
Group 1ExperimentalInsulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=5.6 mmol/L
Receives: Drug: INSULIN GLARGINE
Group 2ExperimentalInsulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=6.1 mmol/L
Receives: Drug: INSULIN GLARGINE
Group 3ExperimentalInsulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=7.0 mmol/L
Receives: Drug: INSULIN GLARGINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with HbA1c <7% achievement

    Measured: 24 weeks

Secondary outcomes (12)

  1. Percentage of patients achieving HbA1c <=6.5%

    Measured: 24 weeks

  2. Percentage of patients achieving FPG target with HbA1c <7%

    Measured: 24 weeks

  3. Percentage of patients achieving HbA1c <7% without hypoglycemia

    Measured: 24 weeks

  4. Percentage of patients achieving the FPG target without hypoglycemia

    Measured: 24 weeks

  5. Percentage of patients achieving FPG target

    Measured: 24 weeks

  6. Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L)

    Measured: 24 weeks

  7. Change from baseline in HbA1c

    Measured: Baseline to 24 weeks

  8. Change in FPG

    Measured: 8 weeks to 24 weeks

  9. Change in PPG

    Measured: Baseline to 24 weeks

  10. Change in insulin doses in each arm

    Measured: 1 week to 24 weeks

  11. Change in body weight in each treatment arm

    Measured: Baseline to 24 weeks

  12. Percentage of patients experienced hypoglycemic events

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2015 (estimated)
  2. Study start7 Sep 2015
  3. Primary completion20 Apr 2018
  4. Study completion20 Apr 2018

Resources

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
947 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545842
Sponsor's protocol ID
LANTUL07190
Other IDs
U1111-1172-1058
Status last verified
Apr 2022
First submitted
8 Sep 2015
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Wang X, Wu G, Shen D, Zhang X, Yang W. Unmet Needs of Glycaemic Control and Risk Factors of Residual Hyperglycaemia in a Chinese Population with Type 2 Diabetes Initiating Basal Insulin: A Post Hoc Analysis of the FPG GOAL Study. Adv Ther. 2022 Jun;39(6):2820-2830. doi: 10.1007/s12325-022-02128-y. Epub 2022 Apr 16.

    PubMed 35430674

  • Li L, Yang T, Xue Y, Ruan P, Du J, Li Y, Zhang X, Cui N, Yang W. Influence of Fasting Plasma Glucose Targets on Glycemic Variability in Chinese Participants With Type 2 Diabetes: A Post Hoc Analysis of the FPG GOAL Trial (BEYOND III). Adv Ther. 2022 Jan;39(1):421-429. doi: 10.1007/s12325-021-01932-2. Epub 2021 Nov 10.

    PubMed 34757600

  • Ma J, Lei M, Li Y, Zhang X, Cui N, Yang W. Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis. Adv Ther. 2020 Sep;37(9):3816-3826. doi: 10.1007/s12325-020-01410-1. Epub 2020 Jul 15.

    PubMed 32671687

  • Yang W, Yang Z, Zhao J, Lu H, Luo T. Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial. Trials. 2016 Sep 26;17(1):470. doi: 10.1186/s13063-016-1588-6.

    PubMed 27669747

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE in people with Type 2 Diabetes Mellitus, run by Sanofi at 44 sites in China.

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 15 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. 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?

Percentage of patients with HbA1c <7% achievement (time frame: 24 weeks). 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 NCT02545842, which also lists 4 linked publications.

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 25 Apr 2022.

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