Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Inclusion criteria:

1. Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure >150 mmHg at Visit 3 (Randomisation visit)
2. Diagnosis of Type 2 diabetes mellitus
3. =18 years of age at the date of signing the informed consent
4. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
5. Ability to provide written informed consent

Exclusion criteria:

1. Pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:

   1. are not surgically sterile; and/or
   2. are nursing or pregnant, or
   3. are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study.

   The only acceptable methods of birth control are:

   • Intrauterine device (IUD);
   • Oral contraceptives (started at least three months prior to start of run-in period)
   • Implantable or injectable contraceptives and
   • Estrogen patch

2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.

3. Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)

4. Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods

5. Patients with Type 1 diabetes mellitus

6. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 µmol /L) or known creatinine clearance <30 mL/min or clinical markers of severe renal impairment

7. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney

8. Clinically relevant hypokalaemia or hyperkalaemia

9. Uncorrected sodium or volume depletion

10. Primary aldosteronism

11. Hereditary fructose intolerance

12. Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency

13. Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)

14. Contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period)

15. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator

16. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

17. Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C >10%

18. Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists

19. History of drug or alcohol dependency within six months prior to signing the informed consent form

20. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol

21. Any investigational drug therapy within one month of signing the informed consent

22. Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)

23. History of non-compliance or inability to comply with prescribed medications or protocol procedures

24. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine