Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01158625

Enrollment

Registered

2010-07-08

Start date

2010-08-31

Completion date

2012-11-30

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Hypertension

Brief summary

The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.

Detailed description

In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure. Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before. This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.

Interventions

OTHERChange of time of administration

Change of time of administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Systolic nighttime blood pressure above 120 mm Hg * Systolic daytime blood pressure not exceeding 150 mm Hg * Antihypertensive treatment which must include * once-daily drugs * at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.

Exclusion criteria

* MI or stroke within 6 months * heart failure (EF \< 45 %) * atrial fibrillation * eGFR \< 30 ml/min

Design outcomes

Primary

Measure	Time frame
Blood pressure, nighttime blood pressure and 24 h blood pressure	After 16 weeks

Secondary

Measure	Time frame
Urine albumin excretion	After 16 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026