Phase 3
Completed N=873
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Source: ClinicalTrials.gov NCT01708902 ↗Enrolled (actual)
873
Serious AEs
1.4%
Results posted
Apr 2015
Primary outcomePrimary: The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group — -1.29; -1.64; -2.07; -2.15 percentage — p=0.0587
Summary
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group |
-1.29; -1.64; -2.07; -2.15; -2.29 | 0.0587 |
| PRIMARY The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC) |
-1.34; -1.68; -2.08; -2.16; -2.38 | 0.0109 sig |
| PRIMARY The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG |
-3.46; -4.71 | 0.0001 sig |
| SECONDARY The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group |
43.6; 50.0; 69.0; 72.1; 77.1 | 0.0771 |
| SECONDARY The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG |
27.1; 58.8 | 0.0001 sig |
| SECONDARY The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group |
23.4; 34.7; 50.4; 56.3; 60.3 | 0.0480 sig |
| SECONDARY The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG |
15.7; 36.8 | 0.0062 sig |
| SECONDARY The Occurrence of Relative Efficacy Response in Main Group |
73.0; 80.6; 89.5; 93.0; 89.4 | 0.9705 |
| SECONDARY The Occurrence of Relative Efficacy Response in APG |
84.3; 91.2 | 0.2523 |
| SECONDARY The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group |
-15.03; -29.87; -42.07; -39.33; -47.44 | 0.0971 |
| SECONDARY The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG |
-56.70; -91.92 | 0.0002 sig |
| SECONDARY The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group |
7.1; 2.1; 0.0; 1.4; 2.1 | 0.0271 sig |
| SECONDARY The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG |
10.0; 1.5 | 0.0474 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent
- Male and female patients on diet and exercise regimen who are drug-naïve
- Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 % /= 11.0 % for the additional parallel group
- Age >/= 18 and 120 % during 2 weeks placebo run in period
- Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation
- Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a
- Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
- Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
- Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
- Pre-menopausal women (last menstruation </= 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
- Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) < 60 ml/min
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- Dehydration by clinical judgement of the investigator
- Clinical detected unstable or acute congestive heart failure
- Acute or chronic metabolic acidosis (present in patient history)
- Hereditary galactose intolerance
- Known history of pancreatitis and chronic pancreatitis
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
Data sourced from ClinicalTrials.gov (NCT01708902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.