Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes.

Wysham C, Lush C, Zhang B, Maier H, Wilhelm K

Current medical research and opinion1 Jan 2008Cited by 21 (Europe PMC)

PMID18031595DOI10.1185/030079908x253537PepBankPUB-18031595

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, pramlintide reduced weight while placebo increased weight.
In plain wordsIn patients with type 2 diabetes, weight decreased with pramlintide and increased with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight
Study
n = 211
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Measurements
Weight change
−1.6 kg
pramlintide
Weight change
0.7 kg
placebo
Source sentences
Summary
Pramlintide-treated patients lost weight and placebo-treated patients gained weight during 16 weeks of treatment (-1.6 +/- 0.3 kg vs. +0.7 +/- 0.3 kg, p < 0.001; mean +/- SE).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159501
02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, pramlintide reduced hsCRP compared with placebo.
In plain wordsIn patients with type 2 diabetes, pramlintide reduced the inflammation marker hsCRP compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHigh sensitivity C-reactive protein
Study
n = 211
Comparator
Placebo
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Measurements
hsCRP change
−0.8 mg/L
pramlintide
hsCRP change
0.1 mg/L
placebo
Source sentences
Summary
hsCRP was reduced in pramlintide-treated versus placebo-treated patients (-0.8 +/- 0.2 mg/L vs. 0.1 +/- 0.2 mg/L, p < 0.01; mean +/- SE).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159502
03HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, HDL changes did not differ significantly between pramlintide and placebo.
In plain wordsIn patients with type 2 diabetes, HDL changes did not differ significantly between pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeHDL
Study
n = 211
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Source sentences
Summary
No significant differences between pramlintide and placebo were observed for changes in HDL, LDL, or blood pressure.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159506
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, LDL changes did not differ significantly between pramlintide and placebo.
In plain wordsIn patients with type 2 diabetes, LDL changes did not differ significantly between pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeLDL
Study
n = 211
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Source sentences
Summary
No significant differences between pramlintide and placebo were observed for changes in HDL, LDL, or blood pressure.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159507
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, blood pressure changes did not differ significantly between pramlintide and placebo.
In plain wordsIn patients with type 2 diabetes, blood pressure changes did not differ significantly between pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeBlood pressure
Study
n = 211
Comparator
Placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Source sentences
Summary
No significant differences between pramlintide and placebo were observed for changes in HDL, LDL, or blood pressure.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159508
06HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, mild-to-moderate nausea was more frequent with pramlintide than placebo.
In plain wordsIn patients with type 2 diabetes, mild-to-moderate nausea was more frequent with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseNausea
Study
n = 211
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Measurements
Nausea
31%
pramlintide
Nausea
10%
placebo
Source sentences
Summary
The most frequent adverse event related to pramlintide was mild-to-moderate nausea (31% pramlintide vs. 10% placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159510
07HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, adding pramlintide to basal insulin did not increase hypoglycemia incidence.
In plain wordsIn patients with type 2 diabetes, pramlintide did not increase low blood sugar compared with placebo on basal insulin.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeHypoglycemia incidence
Study
n = 211
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Source sentences
Summary
Pramlintide added to basal insulin did not increase the incidence of hypoglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159511
08HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes and baseline hsCRP > 3 mg/L, pramlintide reduced hsCRP more than placebo.
In plain wordsIn patients with type 2 diabetes and high baseline hsCRP, pramlintide reduced hsCRP more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreasehsCRP in high-risk subgroup
Study
n: not reported in source
Comparator
Placebo
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Source sentences
Summary
Patients with baseline hsCRP > 3 mg/L (high cardiovascular risk) demonstrated greater hsCRP reductions with pramlintide versus placebo treatment at Week 16 (p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159503
09HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes and triglycerides at least 150 mg/dL, triglycerides decreased with pramlintide but not placebo.
In plain wordsIn patients with type 2 diabetes and high triglycerides, triglycerides decreased from baseline with pramlintide but not placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseTriglycerides with baseline at least 150 mg/dL
Study
n: not reported in source
Comparator
Baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Measurements
Triglyceride change
−43 mg/dL
baseline at least 150 mg/dL; pramlintide
Triglyceride change
1 mg/dL
baseline at least 150 mg/dL; placebo
Source sentences
Summary
Patients with baseline triglycerides > or = 150 mg/dL or > or = 200 mg/dL (high cardiovascular risk) showed significant reductions from baseline in triglyceride concentrations with pramlintide (-43 +/- 14 mg/dL or -59 +/- 19 mg/dL; p < 0.05; mean +/- SE) but not with placebo (1 +/- 29 mg/dL or -3 +/…
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159504
10HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes and triglycerides at least 200 mg/dL, triglycerides decreased with pramlintide but not placebo.
In plain wordsIn patients with type 2 diabetes and high triglycerides, triglycerides decreased from baseline with pramlintide but not placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseTriglycerides with baseline at least 200 mg/dL
Study
n: not reported in source
Comparator
Baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Measurements
Triglyceride change
−59 mg/dL
baseline at least 200 mg/dL; pramlintide
Triglyceride change
−3 mg/dL
baseline at least 200 mg/dL; placebo
Source sentences
Summary
Patients with baseline triglycerides > or = 150 mg/dL or > or = 200 mg/dL (high cardiovascular risk) showed significant reductions from baseline in triglyceride concentrations with pramlintide (-43 +/- 14 mg/dL or -59 +/- 19 mg/dL; p < 0.05; mean +/- SE) but not with placebo (1 +/- 29 mg/dL or -3 +/…
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159505
11HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, pramlintide was generally well tolerated.
In plain wordsIn patients with type 2 diabetes, pramlintide was generally well tolerated.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableTolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
60 or 120 mug with major meals · 16 weeksAs given in this study (human).
Source sentences
Summary
Pramlintide treatment was generally well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N = 211) using insulin glargine (without mealtime insulin) +/- oral agents.
Summary · context
Patients were randomized to treatment with placebo or pramlintide (60 or 120 mug with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of > or = 70 to < 100 mg/dL.
Report a problemFND-1803159509

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT00240253

A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

AstraZenecan = 200Oct 2005 to Jun 2006

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 31 Mar 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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