JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients (JUBILEE)

• ClinicalTrials.gov Identifier: NCT01269996
• Recruitment Status: Completed
• First Posted: January 5, 2011
• Last Update Posted: August 24, 2015
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Juliana Chan, Chinese University of Hong Kong

Study Description

Brief Summary:

To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal insulin in Type 2 Diabetes Mellitus patients.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Janumet, Lantus; Drug: metformin, gliclazide, protaphane	Phase 4

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients
• Study Start Date: May 2011
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Metformin followed by gliclazide and protaphane	Drug: Janumet, Lantus; In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated. Treatment groups: Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection. Group 2 - Janumet followed by Lantus insulin injection.; Drug: metformin, gliclazide, protaphane; In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated. Treatment groups: Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection. Group 2 - Janumet followed by Lantus insulin injection.
Active Comparator: Janumet followed by Lantus insulin injection	Drug: Janumet, Lantus; In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated. Treatment groups: Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection. Group 2 - Janumet followed by Lantus insulin injection.; Drug: metformin, gliclazide, protaphane; In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated. Treatment groups: Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection. Group 2 - Janumet followed by Lantus insulin injection.

Outcome Measures

Primary Outcome Measures :

1. To evaluate the treatment efficacy [ Time Frame: one year ]
   The change in HbA1c in 1 year compare to baseline.

Secondary Outcome Measures :

1. proportion of patients with HbA1c <6.5% in 1 year [ Time Frame: one year ]

   Secondary Outcome Measure: The proportion of patients with HbA1c <6.5% in 1 year.

   Other outcome measures: a)The change in body weight compare to baseline. b)Frequency of hypoglycaemia . Hypoglycemia is defined according to the ADA definitions and classifications of hypoglycaemia.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adult patients aged 18 to 80 years old at Visit 1.
2. Male or female of Chinese ethnicity.
3. Type 2 diabetic patients who are drug naïve with HbA1c ranged between 7.0% to 11.0%.
4. Type 2 diabetic patients who are on single oral hypoglycaemic drug treatment or insulin treatment of duration less than 6 months are eligible after at least 3 months of washout period with diet control only prior to Visit 1 and satisfy the inclusion criteria of HbA1c ranged between 7.0% to 11.0%.
5. Patient understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.
6. Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during study and follow-up period.

Exclusion Criteria:

1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
2. Patients with HbA1c 9% to 11% who have severe symptoms and showing signs of decompensation (e.g. rapid weight loss and ketonuria) due to hyperglycaemia.
3. On anti-obesity drugs 12 weeks prior to informed consent, patient in a weight loss program or intends to be involved in weight loss intervention outside that prescribed by the study.
4. Patient has renal impairment defined as serum creatinine equal to/more than 123 umol/l (1.4mg/dL) in female and serum creatinine equal to/more than 132 umol/l (1.5mg/dL) in male.
5. Significant liver impairment (ALT equal to /more than 2 times upper limit of normal range) or a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, liver cirrhosis or symptomatic gallbladder disease.
6. Any history of cardiovascular disease, stroke or peripheral vascular disease.
7. Any symptoms of ischaemic heart disease like angina.
8. Renal transplant patients.
9. Active malignant disease. Patients with malignant disease who have been successfully treated and disease-free for at least 5 years are eligible. However, patients with a history of leukaemia, lymphoma, aplastic anaemia, myeloproliferative or myelodysplastic disease, thrombocytopenia, malignant melanoma, or renal cell carcinoma are ineligible for the study regardless of the time since treatment.
10. Patient has medical history that indicates a life expectancy of less than 5 years or might limit the individual's ability to take trial treatments for the duration of the study.
11. Patient has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose a risk to the patient, make participation not in the patient's best interest, confound the results of the study (e.g. if patient cannot comply with requirements of the study), or interfere with the patient's participation for the full duration of the study.
12. Patient has a known history of hypersensitivity, intolerance or any contraindication to either metformin, sulfonylurea, DPP-IV inhibitor or insulin.
13. Active and uncontrolled thyroid diseases or active endocrine diseases like Cushing's syndrome or acromegaly.
14. Pre-menopausal women (last menstruation 1 year prior to signing informed consent) who: are nursing or pregnant, or are of child-bearing potential and are not practicing an acceptable and reliable contraceptive methods, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
15. Any medical illness or condition as judged by the investigators as ineligible to participate the study.
16. Special population, e.g. prisoner, mentally disabled, persons with psychiatric disorders and investigators' student or employees.
17. Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of screening or signing the informed consent and does not agree to refrain from participating in any other study while participating in this study.
18. Patient has undergone surgery within the prior 12 weeks or has major surgery planned during the study.

19. Patient is on or is likely to require treatment with equal to/ more than 14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.

    Note: Inhaled, nasal, and topical corticosteroids are permitted.

20. Patient has a clinically significant laboratory or ECG abnormality which, in the opinion of the investigator, exposes the patient to risk by enrolling in the study.
21. History of drug abuse or alcohol abuse. History of recreational or illicit drugs used. Alcohol abuse includes heavy alcohol intake as defined by more than 2 drinks per day or more than 14 drinks per week, or binge drinking.
22. Patient has a clinically significant haematological disorder (e.g., aplastic anaemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia, thalassaemia or thalassaemia trait).
23. Blood donation 3 months prior to the start of the study and during the whole study period.

Contacts and Locations

Locations

Hong Kong

Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

• Principal Investigator: Juliana CN CHAN, FRCP, MD; Chinese University of Hong Kong

More Information

• Responsible Party: Juliana Chan, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01269996 History of Changes
• Other Study ID Numbers: CRE-2010.523
• First Posted: January 5, 2011
• Last Update Posted: August 24, 2015
• Last Verified: August 2015

Keywords provided by Juliana Chan, Chinese University of Hong Kong:

type 2 diabetes mellitus; JUBILEE Study; Janumet; Lantus

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Gliclazide; Hypoglycemic Agents; Physiological Effects of Drugs